UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): November 19, 2013

 

 

Clovis Oncology, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-35347   90-0475355

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

2525 28 th Street, Suite 100

Boulder, Colorado

  80301
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (303) 625-5000

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


On November 19, 2013, we acquired all of the issued and outstanding capital stock of EOS (Ethical Oncology Science) S.p.A., an Italian corporation (“EOS”), and thereby gained rights to develop and commercialize in the U.S. and Japan a compound known as lucitanib, an oral, potent, selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 and vascular endothelial growth factor receptors 1 through 3. In addition, we gained the rights to any future consideration due to EOS under the terms of an agreement whereby EOS sublicensed development and commercialization rights for lucitanib to Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) in territories outside the U.S., Japan, and China.

 

Item 1.01 Entry Into a Material Definitive Agreement.

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

Stock Purchase Agreement

On November 19, 2013, Clovis Oncology, Inc. (the “Company” or “Clovis”) acquired (the “Acquisition”) all of the issued and outstanding capital stock of EOS pursuant to the terms set forth in that certain Stock Purchase Agreement, dated as of November 19, 2013 (the “Stock Purchase Agreement”), by and among the Company, EOS, its shareholders (the “Sellers”) and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ representative. Following the Acquisition, EOS became a wholly-owned subsidiary of the Company. Under the terms of the Stock Purchase Agreement, the Company paid a purchase price comprised of $10,000,000 in cash and 3,713,731 shares of the Company’s common stock, par value $.001 per share (“Company Common Stock”), subject to customary adjustments for working capital acquired in the Acquisition. In addition, pursuant to the Stock Purchase Agreement, the Company will also be obligated to pay to the Sellers certain milestone payments upon the successful development and commercialization by the Company and Servier of lucitanib. Specifically, the Company is obligated to pay Sellers (i) a milestone payment of $65,000,000 upon obtaining the first New Drug Application approval from the U.S. Food and Drug Administration with respect to lucitanib, (ii) a milestone payment of €15,000,000 upon receipt of a milestone payment from Servier pursuant to the Servier Agreement (as defined below) associated with the Marketing Authorization Application filing with the European Medicines Agency for the first indication of lucitanib, (iii) a milestone payment of €45,000,000 upon receipt of a milestone payment from Servier pursuant to the Servier Agreement associated with approval by the European Commission of the first Marketing Authorization for the first indication of lucitanib, and (iv) a milestone payment of €55,000,000 upon the receipt of a milestone payment from Servier pursuant to the Servier Agreement associated with the aggregate net sales of the development compound reaching a specified threshold in any four consecutive calendar quarters. The Stock Purchase Agreement includes customary representations, warranties, covenants and indemnities.

The foregoing description of the Stock Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Stock Purchase Agreement, which is filed as Exhibit 2.1 hereto and is incorporated herein by reference. The representations and warranties contained in the Stock Purchase Agreement were made only for the purposes of the Stock Purchase Agreement and solely for the benefit of the parties thereto. Those representations and warranties may be subject to important limitations and qualifications agreed to by the contracting parties. Some of those representations and warranties may not be accurate or complete as of any particular date because they are subject to contractual standards of materiality different from that generally applicable to public disclosures to stockholders. Furthermore, the representations and warranties may have been made for the purposes of allocating contractual risk between the parties to such contract or other document instead of establishing these matters as facts, and they may or may not have been accurate as of any specific date and do not purport to be accurate as of the date of this Current Report on Form 8-K. Accordingly, you should not rely upon the representations and warranties in the Stock Purchase Agreement as statements of factual information.

Registration Rights Agreement

In connection with the Acquisition, the Sellers and the Company entered into a Registration Rights Agreement, dated as of November 19, 2013 (the “Registration Rights Agreement”), pursuant to which the Company granted registration rights to the Sellers concerning the resale of the shares of Company Common Stock issued to the Sellers pursuant to the Stock Purchase Agreement. The Registration Rights Agreement requires the Company to, promptly following the Acquisition, file a resale registration statement covering the resale of the shares of Company Common Stock issued to the Sellers pursuant to the terms of the Stock Purchase Agreement and help facilitate one underwritten offering for the account of the Sellers. The Company is obligated to use commercially reasonable efforts to keep the registration statement effective as long as the Sellers hold registrable securities.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the Registration Rights Agreement, which is filed as Exhibit 4.1 hereto and is incorporated herein by reference.

 

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Acquisition of EOS

This Current Report on Form 8-K provides the historical financial statements of EOS and its subsidiaries required under Item 9.01(a) and the pro forma financial information required under Item 9.01(b), and an overview of EOS’ business, which consists of the right to develop and commercialize lucitanib, is set forth below.

EOS (Ethical Oncology Science) S.p.A.

Lucitanib – a FGFR and VEGFR Inhibitor

Overview

Lucitanib, also known as E-3810/S 80881, is an oral, potent, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor (VEGF) receptors 1 through 3 (VEGFR1-3). EOS has in-licensed exclusive development and commercial rights to lucitanib on a global basis, excluding China, from Advenchen Laboratories LLC, a small pharmaceutical company focusing on pharmaceutical research and development involving small molecule cancer drug discovery programs. EOS, in turn, sublicensed lucitanib rights to markets outside of the U.S. and Japan to Servier. We intend to collaborate with Servier on the clinical development of lucitanib.

In a Phase I/IIa clinical study, lucitanib demonstrated multiple objective responses in FGFR1 gene-amplified breast cancer patients, and objective responses were also observed in patients with tumors often sensitive to VEGFR inhibitors, such as renal cell and thyroid cancer. FGFR amplification is common in a number of tumor types, including breast cancer and non-small cell lung cancer, and we intend to study lucitanib in these cancers as well as other solid tumors exhibiting FGFR pathway activation.

FGF and VEGF

Fibroblast growth factors (FGFs) are involved in cancer cell proliferation and new blood vessel formation. FGFs are a family of related extracellular proteins that normally regulate cell proliferation and survival in humans. They act by binding to and activating FGF receptors, or FGFRs, which are cell surface proteins that transmit growth signals to cells. Certain FGFs promote growth of multiple solid tumors by binding and activating FGFRs.

The FGF family consists of 22 known proteins called ligands that exert their physiological effect on cells by binding to four FGFRs (FGFR1, 2, 3 and 4). Some tumors contain an excessive number of FGFR1 gene copies, generated by a process called gene amplification. Amplification of the FGFR1 gene results in excess production, or the over-expression, of FGFR1 protein on the surface of the tumor cell. The over-expression of FGFR1 on the tumor cell surface leads to an increased binding of FGF ligands, which stimulate uncontrolled proliferation of some types of tumor cells.

In addition to FGFR1 gene amplification, certain tumors contain an excessive number of gene copies encoding FGF ligands 3, 4, and 19. Because these genes are located together on chromosome 11, amplification of FGF 3, 4, and 19 is commonly referred to as 11q amplification. The amplification of these genes in the tumor cell has the potential to increase FGFR activation and tumor growth.

Tumors with a relatively high incidence of FGFR1 and/or 11q gene amplification include breast cancer (10-24%), squamous non-small cell lung cancer (NSCLC) (17-34%), and head and neck cancers (9-35%). In addition, FGFR1/2 gene amplification/mutation is also observed at a frequency of 3-19% in a wide range of cancer indications including sarcoma, ovarian cancer, adenocarcinoma of the lung, bladder cancer, colorectal cancer and endometrial cancer.

The FGFR signaling pathway can also be activated in tumors by the mutation of genes encoding the FGF receptors. FGFR gene mutation alters the structure of the FGF receptor on the cell surface in such a manner as to trigger FGFR signaling in the absence of ligand binding, thereby stimulating uncontrolled cancer cell growth. In addition, some FGFs can promote tumor growth through the formation of new blood vessels in tumors in a process known as angiogenesis.

In concert with FGFs, VEGFs are also involved in the formation of new blood vessels in tumors. The VEGFs are a family of related extracellular proteins that normally regulate blood and lymphatic vessel development in humans. They act by binding to and activating VEGF receptors, which are cell surface proteins that transmit growth signals to specific cells that are involved in the development of new blood vessels. Certain VEGFs promote growth of multiple solid tumors by stimulating the formation of new blood vessels to feed the tumor and allow it to grow and metastasize. Tumors produce an excessive amount of VEGF. This results in excess VEGFR signaling and the formation of new blood vessels within the tumor. By triggering angiogenesis, cancerous cells can fuel their metabolic needs and direct their own uncontrolled cell division. The FGF and VEGF ligands that cause angiogenesis are often present in a wide range of cancer indications, including a type of kidney cancer called renal cell carcinoma, a type of liver cancer called hepatocellular carcinoma, head and neck cancers, and other solid tumors.

 

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Considering the role of FGFR1/2 and VEGFR1-3 kinases in tumor progression and metastasis formation, as an inhibitor of both FGFR1/2 and VEGFR1-3, lucitanib has the potential benefit of targeting two relevant pro-angiogenic growth factors in targeted patient populations identified by molecular markers.

Opportunity for Clovis

Within the universe of FGFR-inhibitors, we were particularly attracted to the profile of lucitanib from a variety of perspectives:

 

    lucitanib is a very potent and selective inhibitor of FGFR1/2 and VEGFR1-3;

 

    patients whose tumors display suitable target pathway activation can be identified and may derive significant benefit from treatment;

 

    clinical data generated to date for lucitanib demonstrate proof of concept with objective responses commonly seen in FGFR1-amplified breast cancer patients, a target population where we believe pure FGFR inhibitors and pure VEGFR inhibitors have limited activity and utility;

 

    lucitanib has potential for use in combination with estrogen antagonists or as monotherapy in advanced breast cancer patients; and

 

    in squamous lung cancer where FGFR1 gene amplification is common, VEGFR has been validated clinically as a relevant therapeutic target, but FGFR inhibitors have shown only sporadic responses, thus suggesting a development opportunity for lucitanib, which meaningfully attacks both targets.

Clinical Development of lucitanib

The first-in-man clinical trial of lucitanib was initiated in Europe in July 2010 and is currently ongoing. The initial trial is an open-label, dose-escalation, Phase I/IIa study to determine the maximum tolerated dose (MTD), recommended dose, efficacy, pharmacokinetics and pharmacodynamics of oral lucitanib in adult patients with advanced solid tumors. The dose escalation phase started at 5mg once per day and went to 30mg dosed once per day. 20mg was identified as the MTD using a standard dose limiting toxicity (DLT) window definition, but in the heavily pre-treated study population dose reductions because of toxicity were frequent and, therefore, 15mg once per day has been adopted as a starting dose in one Phase II study. Overall, the toxicity profile observed to date is consistent with what was expected from preclinical studies, with hypertension, proteinuria and subclinical hypothyroidism requiring supplementation being commonly observed. Other common treatment-related events include asthenia and gastrointestinal symptoms (diarrhea, abdominal pain, nausea and vomiting). Subsequent to MTD identification, a dose expansion phase was initiated in defined populations expected to derive benefit from lucitanib. These patients were either FGFR or 11q amplified or angiogenesis inhibitor-sensitive patients. Six of twelve FGF aberrant breast cancer patients achieved RECIST partial responses with additional responses seen across other tumor types. Median PFS for these heavily pre-treated breast cancer patients (median of 6 prior lines of therapy) was 9.4 months.

Development Strategy

Based on the initial signals of activity and safety described above, a Phase II program is being initiated to explore lucitanib in multiple indications including a U.S. study in treatment refractory FGF aberrant breast cancer and a global study in FGFR-1 amplified metastatic squamous NSCLC. In parallel with planned Clovis-sponsored studies, a Servier-sponsored Phase II study of lucitanib monotherapy in patients with advanced breast cancer is expected to open to enrollment in the fourth quarter of 2013 in collaboration with The Breast International Group. This ex-US study is expected to enroll approximately 120 patients into 3 cohorts of 40 patients each: (1) FGFR-1 amplified, (2) 11q amplified, and (3) neither FGFR1 nor 11q amplified. This study will seek to determine whether the activity of lucitanib is limited to a biomarker-defined population of breast cancer tumors with FGF-aberrations or if a more broadly defined population may benefit. A European Phase Ib study is being developed by Servier to evaluate safety of lucitanib combined with fulvestrant, an estrogen receptor antagonist, in advanced breast cancer patients.

If these Phase II and Phase Ib combination studies are successfully completed, and assuming confirmation of the activity observed to date, we intend to pursue future development of lucitanib as monotherapy and/or in combination with estrogen antagonists, most likely in FGF-aberrant treatment refractory breast cancer. Other potential indications we may consider include squamous NSCLC, bladder, head and neck cancer, and other solid tumors with FGF-aberrancies.

Clinical development of lucitanib in patients with FGF-aberrant tumors will be accompanied by development of a diagnostic test designed to identify a selected patient population we believe to be the most likely to benefit. In the current Phase Ib and Phase II trial of lucitanib, Servier is using a third

 

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party central lab to test tumor samples from prospective subjects to identify those with FGFR1 gene-amplified tumors. Neither we nor Servier have yet engaged a third party to develop any companion diagnostic that would be used in any future clinical trials of lucitanib or required for the registration and approval of lucitanib.

Lucitanib Competition

There are currently no approved drugs that specifically target both FGFR1 and VEGF. However, there are a number of FGFR inhibitors in development including Novartis’ dovitinib, currently in Phase I/II studies, AstraZeneca’s AZD4547, currently in Phase II trials, Novartis’ BGJ 398, currently in Phase I trials, Johnson and Johnson’s JNJ-42756493, currently in Phase I trials, Eli Lilly’s LY 2874455, currently in a Phase I trial, Debiopharm’s Debio 1357, currently in a Phase I trial, and GlaxoSmithKline’s GSK3052230, currently in a Phase I trial.

Product License Agreements

Advenchen Laboratories LLC

In October 2008, EOS entered into an exclusive license agreement with Advenchen Laboratories LLC (as amended through the date hereof, the “Advenchen Agreement”) to develop and commercialize lucitanib on a global basis, excluding China. If and when commercial sales commence, EOS is obligated to pay Advenchen tiered royalties at percentage rates in the mid-single digits on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, after giving effect to the first and second amendments to the Advenchen Agreement, EOS is required to pay to Advenchen a percent in the mid-twenties of any consideration, excluding royalties, received by EOS from sublicensees, in lieu of the milestone obligations set forth in the agreement. EOS is obligated under the Advenchen Agreement to use commercially reasonable efforts to develop and commercialize at least one product containing lucitanib, and EOS is responsible for all remaining development and commercialization costs for lucitanib.

The Advenchen Agreement will remain in effect until the expiration of all of EOS’ royalty obligations to Advenchen, determined on a product-by-product and country-by-country basis, unless EOS elects to terminate the Advenchen Agreement earlier. If EOS fails to meet its obligations under the Advenchen Agreement and is unable to cure such failure within specified time periods, Advenchen can terminate the Advenchen Agreement, resulting in a loss of our rights to lucitanib.

The foregoing description of the Advenchen Agreement does not purport to be complete and is qualified in its entirety by reference to the Advenchen Agreement, which is filed as Exhibit 10.1 hereto and is incorporated herein by reference.

Les Laboratoires Servier

In September 2012, EOS entered into a collaboration and license agreement with Les Laboratoires Servier and Institut de Recherches Internationales Servier (the “Servier Agreement”) whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan, and China. In exchange for these rights, EOS received an upfront payment of €45 million. Further, EOS is entitled to receive additional payments on the achievement of specified development, regulatory and commercial milestones up to €100 million in the aggregate. In addition, EOS is entitled to receive sales milestone payments if specified annual sales targets for lucitanib are met, each of which relates to annual sales targets of €250 million and above, which, in the aggregate, could amount to total milestone payments of €250 million. EOS is also entitled to receive royalties at percentage rates ranging from low double digits to mid-teens on sales of lucitanib by Servier.

Each of EOS and Servier are obligated to use diligent efforts to develop a product containing lucitanib and to carry out the activities assigned to it under a global development plan agreed to between the parties. Servier is responsible for all of the global development costs for lucitanib up to €80 million, pursuant to a mutually-agreed upon development plan. Cumulative global development costs, if any, in excess of €80 million will be shared between EOS and Servier.

The Servier Agreement will remain in effect until the expiration of all of Servier’s royalty obligations to us, determined on a product-by-product and country-by-country basis, unless Servier elects to terminate the Servier Agreement earlier. If we fail to meet our obligations under the Servier Agreement and are unable to cure such failure within specified time periods, Servier can terminate the Servier Agreement, resulting in the granting of a perpetual license to Servier of rights to lucitanib.

 

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The foregoing description of the Servier Agreement does not purport to be complete and is qualified in its entirety by reference to the Servier Agreement, which is filed as Exhibit 10.2 hereto and is incorporated herein by reference.

Patents and Proprietary Rights

Composition of matter patent protection for lucitanib and a group of structurally related compounds is issued in the United States and is pending in Japan. In the United States, the composition of matter patent will expire in 2030. We believe that patent term extension could be available to extend our composition of matter patent up to five years beyond the scheduled expiration pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act. There is also a method of use patent for lucitanib and a group of structurally related compounds issued in the United States. Additionally, patent applications directed to methods of manufacturing lucitanib are pending in the United States and Japan.

Manufacturing

The active pharmaceutical ingredient for lucitanib is currently being manufactured at a third party contract manufacturer. To date, the current production process has been sufficient to satisfy immediate clinical demands. Additional development work may be performed to further optimize the active pharmaceutical ingredient manufacturing process.

The finished drug product for lucitanib is currently being manufactured at a third party contract manufacturer. The current product and process are sufficiently developed to meet immediate clinical demands. Additional development work is being performed to optimize the drug product formulation and manufacturing process to meet projected clinical and commercial requirements. Identification of an acceptable commercial formulation, suitable manufacturing process, and manufacturing site to prepare that formulation are critical to the successful development of lucitanib. Additional scale-up work and/or additional production capacity will be necessary to support larger clinical development or commercialization requirements.

Facilities

EOS is party to a lease for its headquarters in Milan, Italy, used primarily for corporate functions, with a six-month term expiring on March 31, 2014.

Employees

EOS and its subsidiary, together, have two full time employees, neither of whom is represented by labor unions or covered by collective bargaining agreements (other than the national collective agreement for the chemical and pharmaceutical sector in Italy).

Legal Proceedings

EOS is not currently engaged in any material legal proceedings.

 

Item 3.02 Unregistered Sales of Equity Securities

The description of the Stock Purchase Agreement set forth in Item 1.01 and Item 2.01 above is incorporated by reference into this Item 3.02. Pursuant to the terms and conditions of the Stock Purchase Agreement, on November 19, 2013, the Company issued to the Sellers an aggregate of 3,713,731 shares of Company Common Stock as part of the consideration for the purchase of EOS. The Company offered and sold the Company Common Stock in reliance on the exemption from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506 of Regulation D promulgated under the Securities Act, based on the nature of the investors and certain representations made to the Company.

 

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Item 9.01 Financial Statements and Exhibits.

(a) Financial Statements of Business Acquired

The audited balance sheets of EOS S.p.A. as of December 31, 2012 and 2011, the related statements of operations, stockholders’ equity and cash flows for the years in the three year period ended December 31, 2012, and the notes related thereto, and the related independent auditors’ report of KPMG S.p.A. and the unaudited balance sheet of EOS S.p.A. and subsidiary as of September 30, 2013, the related unaudited statements of operations and cash flows of EOS S.p.A. for the nine months ended September 30, 2013 and 2012, and the related unaudited statement of stockholders’ equity for the nine months ended September 30, 2013 and the notes related thereto are attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. Such financial statements of EOS S.p.A. were prepared in conformity with generally accepted accounting principles in Italy. Accounting principles generally accepted in Italy vary in certain significant respects from U.S. generally accepted accounting principles. Information relating to the nature and effect of such differences is presented in note 14 to the financial statements.

(b) Pro Forma Financial Information

The unaudited pro forma condensed combined financial information for the nine months ended September 30, 2013 and the year ended December 31, 2012, and the notes thereto, is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. The unaudited pro forma condensed combined financial information includes adjustments to convert the basis of the historical financial statements of EOS S.p.A. from accounting principles generally accepted in Italy to U.S. GAAP and to translate Euro amounts into U.S. dollars.

(d) Exhibits .

 

Exhibit
Number

  

Description

  2.1    Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers listed on Exhibit A thereto and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative.*
  4.1    Registration Rights Agreement, dated as of November 19, 2013, by and between the Company and the Sellers signatory thereto.
10.1    Development and Commercialization Agreement, dated as of October 24, 2008, by and between Advenchen Laboratories LLC and Ethical Oncology Science S.p.A., as amended by the First Amendment, dated as of April 13, 2010 and the Second Amendment, dated as of July 30, 2012.**
10.2    Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical Oncology Science S.p.A. and Les Laboratoires Servier and Institut de Recherches Internationales Servier.**
23.1    Consent of KPMG S.p.A., Independent Registered Public Accounting Firm.
99.1    The audited balance sheets of EOS S.p.A. as of December 31, 2012 and 2011, the related statements of operations, stockholders’ equity and cash flows for each of the years in the three year period ended December 31 2012, and the notes related thereto, and the unaudited balance sheet of EOS S.p.A. and subsidiary as of September 30, 2013, the related unaudited statements of operations and cash flows of EOS S.p.A. for the nine months ended September 30, 2013 and 2012, and the related unaudited statement of stockholders’ equity for the nine months ended September 30, 2013 and the notes related thereto.
99.2    The unaudited pro forma combined financial information for the nine months ended September 30, 2013 and the year ended December 31, 2012, and the notes thereto.

 

* The schedules referenced in the Stock Purchase Agreement have been omitted in accordance with Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule will be furnished supplementally to the Securities and Exchange Commission upon request.
** Pursuant to a request for confidential treatment, portions of these Exhibits have been redacted from the publicly filed documents and have been furnished separately to the Securities and Exchange Commission as required by Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this Current Report on Form 8-K and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree of clinical utility of our products, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us. By their nature, forward-looking statements involve risks and uncertainties, including, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates because they relate to events, competitive dynamics, and industry change and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained herein. Factors that could cause or contribute to such differences include, but are not limited to, those factors set forth under “Risk Factors” in our most recent Annual Report on Form 10-K, as revised or supplemented by our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. As a result, you should not place undue reliance on these forward-looking statements. We undertake no obligation to revise these forward-looking statements to reflect future events or developments.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CLOVIS ONCOLOGY, INC.
November 19, 2013     By:  

/s/ Erle T. Mast

    Name:   Erle T. Mast
    Title:   Executive Vice President and Chief Financial Officer


EXHIBIT INDEX

 

Exhibit
Number

  

Description

  2.1    Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers listed on Exhibit A thereto and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative.*
  4.1    Registration Rights Agreement, dated as of November 19, 2013, by and between the Company and the Sellers signatory thereto.
10.1    Development and Commercialization Agreement, dated as of October 24, 2008, by and between Advenchen Laboratories LLC and Ethical Oncology Science S.p.A., as amended by the First Amendment, dated as of April 13, 2010 and the Second Amendment, dated as of July 30, 2012.**
10.2    Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical Oncology Science S.p.A. and Les Laboratoires Servier and Institut de Recherches Internationales Servier.**
23.1    Consent of KPMG S.p.A., Independent Registered Public Accounting Firm.
99.1    The audited balance sheets of EOS S.p.A. as of December 31, 2012 and 2011, the related statements of operations, stockholders’ equity and cash flows for each of the years in the three year period ended December 31 2012, and the notes related thereto, and the unaudited balance sheet of EOS S.p.A. and subsidiary as of September 30, 2013, the related unaudited statements of operations and cash flows of EOS S.p.A. for the nine months ended September 30, 2013 and 2012, and the related unaudited statement of stockholders’ equity for the nine months ended September 30, 2013 and the notes related thereto.
99.2    The unaudited pro forma combined financial information for the nine months ended September 30, 2013 and the year ended December 31, 2012, and the notes thereto.

 

* The schedules referenced in the Stock Purchase Agreement have been omitted in accordance with Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule will be furnished supplementally to the Securities and Exchange Commission upon request.
** Pursuant to a request for confidential treatment, portions of these Exhibits have been redacted from the publicly filed documents and have been furnished separately to the Securities and Exchange Commission as required by Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Exhibit 2.1

STOCK PURCHASE AGREEMENT

by and among

CLOVIS ONCOLOGY, INC.,

EOS (ETHICAL ONCOLOGY SCIENCE) S.P.A. ,

THE SELLERS LISTED ON EXHIBIT A HERETO,

and

SOFINNOVA CAPITAL V FCPR ,

as the

SELLERS’ REPRESENTATIVE

Dated as of November 19, 2013


TABLE OF CONTENTS

 

              Page  
ARTICLE I. DEFINITIONS      1   
  1.1.    Defined Terms      1   
  1.2.    Other Terms      13   
  1.3    Interpretation      13   
ARTICLE II. PURCHASE AND SALE      14   
  2.1.    Purchase and Sale      14   
  2.2.    Closing of the Transactions Contemplated by this Agreement      14   
  2.3.    Deliveries at the Closing.      15   
  2.4.    Subsequent Payments.      17   
  2.5.    Withholding Rights      18   
  2.6.    Working Capital Adjustment.      19   
  2.7.    Escrow Amount.      21   
  2.8.    Sellers’ Representative.      23   
ARTICLE III. REPRESENTATIONS AND WARRANTIES OF THE COMPANY      26   
  3.1.    Organization.      26   
  3.2.    Subsidiaries      27   
  3.3.    Authorization.      27   
  3.4.    Capitalization.      27   
  3.5.    Title to Properties and Assets.      29   
  3.6.    Absence of Certain Activities or Changes:      29   
  3.7.    Material Contracts.      30   
  3.8.    Compliance with Other Instruments.      31   
  3.9.    Financial Statements.      31   
  3.10.    Liabilities.      32   
  3.11.    Taxes.      32   
  3.12.    Environmental Matters.      33   
  3.13.    Employee Benefits.      34   
  3.14.    Compliance with Law.      35   
  3.15.    Permits      35   
  3.16.    Consents and Approvals      35   
  3.17.    Litigation.      36   
  3.18.    Labor Matters.      36   
  3.19.    Intellectual Property.      37   
  3.20.    Transactions with Certain Persons.      39   
  3.21.    Insurance      39   
  3.22.    Certain Business Practices      39   
  3.23.    No Broker.      39   

 

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  3.24.    Books and Records.      40   
  3.25.    Bank Accounts      40   
  3.26.    Drug Regulatory Agency and Related Matters      40   
ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF THE SELLERS      41   
  4.1.    Authorization.      42   
  4.2.    Title to the Shares      42   
  4.3.    Compliance with Other Instruments      42   
  4.4.    Consents and Approvals      42   
  4.5.    Litigation      43   
  4.6.    [Intentionally left blank].      43   
  4.7    No Broker.      43   
  4.8.    Accredited Investor.      43   
  4.9.    Acquisition for Investment.      43   
  4.10.    Disclosure      43   
  4.11.    Restricted Securities.      43   
  4.12.    No General Solicitation.      44   
ARTICLE V. REPRESENTATIONS AND WARRANTIES OF BUYER      44   
  5.1.    Organization      44   
  5.2.    Authorization      45   
  5.3.    Compliance with Other Instruments.      45   
  5.4.    Compliance with Law      45   
  5.5.    Consents and Approvals.      45   
  5.6.    Litigation.      45   
  5.7.    No Broker      46   
  5.8.    SEC Filings.      46   
  5.9.    Limited Representations      46   
  5.10.    Buyer Common Stock.      46   
ARTICLE VI. ADDITIONAL AGREEMENTS      47   
  6.1.    Conduct of Business by the Company      47   
  6.2.    Confidentiality      47   
  6.3.    Public Disclosure.      47   
  6.4.    [Intentionally left blank].      48   
  6.5.    Buyer Director.      48   
  6.6.    Covenant Not to Compete.      48   
  6.7.    Resignation of Statutory Auditors.      48   
  6.8.    Indemnification of Directors and Officers.      48   
  6.9.    Tax Matters.      49   
  6.10.    Development and Commercialization of the Development Products.      50   
  6.11.    Seller Release.      50   
  6.12.    Buyer Release.      51   
  6.13.    Further Assurances      52   

 

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ARTICLE VII. INDEMNIFICATION      52   
  7.1.    Survival of Representations.      52   
  7.2.    Indemnification.      53   
  7.3.    Notice of Claims.      54   
  7.4.    Third Person Claims.      54   
  7.5.    Limitations on Indemnity; Payments Out of Subsequent Consideration.      55   
  7.6.    Remedies      56   
ARTICLE VIII. MISCELLANEOUS      57   
  8.1.    Binding Effect; Assignment      57   
  8.2.    Notices      57   
  8.3.    Choice of Law.      59   
  8.4.    Entire Agreement; Amendments and Waivers.      59   
  8.5.    Counterparts      59   
  8.6.    Severability      59   
  8.7.    Headings      59   
  8.8.    Schedules      59   
  8.9.    No Third Party Beneficiaries.      59   
  8.10.    Specific Performance      60   
  8.11.    No Strict Construction      60   
  8.12.    Expenses      60   
  8.13.    Arbitration.      60   

LIST OF EXHIBITS

 

Exhibit A

   Sellers

Exhibit B

   Escrow Agreement

Exhibit C

   Registration Rights Agreement

Exhibit 2.3(a)(vi)

   Non-Compete and Non-Solicit Persons

Exhibit 2.3(a)(x)

   Resignation letter by the directors

Exhibit 2.3(b)(iv)

   Debt Payoff Amount

Exhibit 2.3(b)(viii)

   Form of Release Letter

Exhibit 2.3(c)

   Transaction Consideration

Exhibit 6.6(a)

   Non-Competition Items

Exhibit 6.8(a)

   Indemnification Resolutions and Agreements

Schedule I

   Closing Date Net Working Capital Example

 

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STOCK PURCHASE AGREEMENT

This STOCK PURCHASE AGREEMENT (this “ Agreement ”), dated as of November 19, 2013, is entered into by and among Clovis Oncology, Inc., a Delaware corporation (“ Buyer ”), EOS (Ethical Oncology Science) S.p.A., an Italian corporation (the “ Company ”), each of the persons listed on Exhibit A hereto (each, a “ Seller ” and together, the “ Sellers ”), and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative in connection with the transactions contemplated by this Agreement (the “ Sellers’ Representative ”) (hereafter, Buyer, the Company, each Seller and the Sellers’ Representative shall sometimes be referred to as the “ Parties ”).

RECITALS

WHEREAS, the Sellers collectively own beneficially, and of record, all of the issued and outstanding capital stock of the Company (the “ Shares ”), consisting of Ordinary Shares (as defined below) and Preferred Shares (as defined below).

WHEREAS, the Parties desire that, upon the terms and subject to the conditions in this Agreement, Buyer shall purchase from the Sellers, and the Sellers shall sell to Buyer, the Shares held by the Sellers in exchange for the consideration set forth in this Agreement.

AGREEMENT

NOW THEREFORE, in consideration of the respective covenants and promises contained herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE I.

DEFINITIONS

1.1. Defined Terms . As used herein, the terms below shall have the following meanings. Any of such terms, unless the context otherwise requires, may be used in the singular or plural, depending upon the reference.

Affiliate ” means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by or is under common control with such Person; as used in this definition, “control” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract or otherwise.

Aggregate Outstanding Claims ” has the meaning set forth in Section 2.7(b) .

Agreement ” has the meaning set forth in the Preamble.

Applicable Law ” means, with respect to any Person, any federal, state, local or other domestic or non-U.S. statute, law, ordinance, rule, regulation, order, arbitral decision, writ, injunction, judgment, award, decree, agency guidelines or other requirement of any Governmental Authority applicable to such Person or any of such Person’s property, assets, officers, directors, employees, consultants or agents.


Benefit Plans ” has the meaning set forth in Section 3.13(a) .

Bonus Agreements ” shall mean the bonus letter agreements set forth on Schedule 1.1(a) .

Business Day ” means a day other than a Saturday, Sunday or other day on which commercial banks in New York, New York or Milan, Italy are authorized or required by law to close.

Buyer ” has the meaning set forth in the Preamble, except where there is an affirmative or negative obligation hereunder on behalf of Buyer, in which case “ Buyer ” shall mean collectively Buyer and its Subsidiaries (including after the Closing, the Group Companies).

Buyer Common Stock ” means the common stock, par value $0.001 per share, of Buyer.

Buyer Indemnified Parties ” has the meaning set forth in Section 7.2(a)(i) .

Buyer Released Claims ” has the meaning set forth in Section 6.12(b) .

Buyer Released Obligations ” has the meaning set forth in Section 6.12(a) .

Buyer Released Parties ” has the meaning set forth in Section 6.12(a) .

Buyer’s SEC Reports ” shall mean any Current Report on Form 8-K filed by Buyer between January 1, 2013 and the date hereof, the Annual Report on Form 10-K for the fiscal year ended December 31, 2012 of Buyer and any Quarterly Report on Form 10-Q for fiscal quarters ending thereafter and prior to the date hereof of Buyer, each as filed with the U.S. Securities and Exchange Commission.

Cash ” means all cash and cash equivalents.

Claim Notice ” has the meaning set forth in Section 7.3 .

Closing ” has the meaning set forth in Section 2.2 .

Closing Date ” has the meaning set forth in Section 2.2 .

Closing Date Balance Sheet ” means an unaudited, consolidated balance sheet of the Group Companies as of 11:59 p.m., Italian time, on the Closing Date (without giving effect to the transactions contemplated by this Agreement), prepared in accordance with Italian GAAP, consistently applied.

 

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Closing Date Net Working Capital ” means (A) the Group Companies’ total Current Assets as of 11:59 p.m., Italian time, on the Closing Date, minus (B) the Group Companies’ total Current Liabilities as of 11:59 p.m., Italian time, on the Closing Date (other than deferred Tax liabilities that reflect timing differences between book and tax accounting), in each case determined in accordance with Italian GAAP, consistently applied and applying the same accounting principles and methodologies used to prepare the Most Recent Balance Sheet; provided , however , when computing Closing Date Net Working Capital, the following adjustments shall be made: (a) Current Assets shall include any and all Cash of the Group Companies to the extent not already included as a Current Asset; (b) Current Liabilities shall include any and all Indebtedness of the Group Companies to the extent not already included as a Current Liability; and (c) Current Liabilities shall include any unpaid Transaction Expenses to the extent not already included as a Current Liability. Closing Date Net Working Capital shall be calculated in U.S. dollars using an exchange ratio of $1.35 per €1. Schedule I hereto sets forth an example of the calculation of Closing Date Net Working Capital as of September 30, 2013, derived from the Company’s consolidated September 30, 2013 balance sheet.

Code ” means the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.

Collaboration and License Agreement ” means the Collaboration and License Agreement, dated September 28, 2012, by and between the Company and Servier, as amended to the date hereof, attached hereto as Schedule 1.1(c) .

Company ” has the meaning set forth in the Preamble.

Company Partner ” has the meaning set forth in Section 3.26(b) .

Company Subsidiary ” means EOS-CS (ETHICAL ONCOLOGY SCIENCE – CLINICAL STUDIES) S.r.l.

Conclusive Net Working Capital Adjustment Statement ” has the meaning set forth in Section 2.6(e) .

Conclusive Net Working Capital Statement ” has the meaning set forth in Section 2.6(e) .

Confidential Information ” has the meaning set forth in Section 6.2 .

Court Order ” means any judgment, decision, consent decree, injunction, ruling or order of any federal, state, local or other domestic or non-U.S. court or Governmental Authority that is binding on any Person or its property.

Covered Parties ” has the meaning set forth in Section 7.2(a)(iii) .

Covered Person ” has the meaning set forth in Section 6.8(a) .

Current Assets ” means the consolidated account receivables, VAT tax receivables and other receivables of the Group Companies (but shall exclude withholding Tax receivables).

 

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Current Liabilities ” means the consolidated Employee termination amount (TFR ex lege), trade payables, Tax payables, social security payables, payables for 2012 dividend payment to shareholders, other payables, MIP payables, and Stifel termination fee; provided , however, Current Liabilities shall not include Indebtedness, Transaction Expenses and amounts owed under Severance Agreements (to the extent not included in Transaction Expenses).

D&O Tail ” has the meaning set forth in Section 6.8(b) .

Damages ” has the meaning set forth in Section 7.2(a)(i) .

Debt Payoff Amount ” has the meaning set forth in Section 2.3(b)(iv) .

Deductible Amount ” has the meaning set forth in Section 7.5(a) .

Default ” means (a) any actual breach or default or (b) the occurrence of an event that with the passage of time or the giving of notice or both would constitute a breach or default.

Development Compound ” means, for the purposes of Article III (including in the defined terms used therein), E-3810, as developed by the Group Companies prior to the Closing, and, for all other purposes hereunder, including with respect to Section 6.10 , as developed by Buyer and its Affiliates following the Closing.

Development Product ” means any product containing the Development Compound.

Disclosure Schedule ” has the meaning set forth in Article III .

Dispute Notice ” has the meaning set forth in Section 2.8(g) .

Disputed Items ” has the meaning set forth in Section 2.6(c) .

Drug Regulatory Agency ” means the EMA, FDA or any other federal, state, local or non-U.S. governmental entity that is concerned with the safety, efficacy, reliability, manufacturing, labeling, marketing, or advertising of drug products.

EMA ” means the European Medicines Agency.

EMA Milestone ” has the meaning set forth in the definition of “EMA Subsequent Payment Date” in Section 1.1 .

EMA Subsequent Payment Amount ” has the meaning set forth in Section 2.4(b) .

EMA Subsequent Payment Date ” means the fifth (5th) Business Day following the date when the milestone payment from Servier (or its successors) associated with the Marketing Authorization Application filing with the EMA for the first indication of the Development Compound as per section 8.4(b) of the Collaboration and License Agreement is received by the Company or its Affiliates or designees under the Collaboration and License Agreement, the receipt of such milestone payment being the “ EMA Milestone .”

 

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Encumbrance ” means any claim, lien, pledge, option, charge, easement, security interest, deed of trust, mortgage, conditional sales agreement or encumbrance, whether voluntarily incurred or arising by operation of law, and includes any agreement to give any of the foregoing in the future. For the avoidance of doubt, the foregoing shall not include licenses of or other grants of rights to use Intellectual Property.

Environmental Claim ” means, in respect of any Person, (i) any and all administrative, regulatory or judicial actions, suits, orders, decrees, demands, directives, claims, liens, proceedings or written notices of noncompliance or violation by any Governmental Authority, alleging potential presence or release of, or exposure to, any Hazardous Materials at any location, whether or not owned, operated, leased or managed by such Person, or (ii) any and all indemnification, cost recovery, compensation or injunctive relief resulting from the presence or release of, or exposure to, any Hazardous Materials.

Environmental Laws ” has the meaning set forth in Section 3.12 .

Escrow Account ” has the meaning set forth in Section 2.7(a) .

Escrow Agent ” has the meaning set forth in Section 2.7(a) .

Escrow Agreement ” has the meaning set forth in Section 2.7(a) .

Escrow Amount ” has the meaning set forth in Section 2.7(a) .

Escrow Earnings ” has the meaning set forth in Section 2.7(c) .

Escrow Expiration Date ” means the date that is twelve (12) months following the Closing Date.

Estimated Cash Consideration ” means $9,000,000 plus (a) the Estimated Net Working Capital Excess Amount set forth on the Estimated Net Working Capital Adjustment Statement, if any, minus (b) the Estimated Net Working Capital Deficiency Amount set forth on the Estimated Net Working Capital Adjustment Statement, if any.

Estimated Net Working Capital ” has the meaning set forth in Section 2.6(a) .

Estimated Net Working Capital Adjustment Statement ” has the meaning set forth in Section 2.6(a) .

Estimated Net Working Capital Deficiency Amount ” has the meaning set forth in Section 2.6(a) .

Estimated Net Working Capital Excess Amount ” has the meaning set forth in Section 2.6(a) .

 

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Estimated Net Working Capital Statement ” has the meaning set forth in Section 2.6(a) .

Exchange Act ” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

FDA ” means the United States Food and Drug Administration.

Financial Statements ” has the meaning set forth in Section 3.9 .

GAAP ” means generally accepted accounting principles consistently applied over all relevant periods.

Good Clinical Practices ” means the then current standards for clinical trials for pharmaceuticals, as defined in the ICH Harmonised Tripartite Guideline For Good Clinical Practice E6(R1), together with such other requirements in the European Union as are specified in Directive 2001/20/EC and Directive 2005/28/EC relating to medicinal products for human use, and in guidance published by the European Commission pursuant to such Directives, and such standards of good clinical practice as are required by the regulatory authorities of the member countries of the European Union.

Good Laboratory Practices ” means the then current standards for non-clinical research studies, as are specified in Directive 2004/9/EC and Directive 2004/10/EC relating to good laboratory practice, and in guidance published by the European Commission pursuant to such Directives, and such standards of good laboratory practices as are required by the regulatory authorities of the member countries of the European Union.

Good Manufacturing Practices ” means the then current standards for the manufacture, processing, packaging, testing and holding of medicinal products, as specified in Directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively, and such standards of good manufacturing practices as are required by the regulatory authorities of the member countries of the European Union.

Governmental Authority ” means any court, administrative agency, regulatory body, commission or other governmental authority or instrumentality of the United States or any other country or any state, county, municipality or other governmental division of any country or any stock exchange.

Group Companies ” means the Company and the Company Subsidiary.

Hazardous Materials ” has the meaning set forth in Section 3.12 .

HSR Act ” has the meaning set forth in Section 3.16 .

Indebtedness ” means (without duplication), as to any Person, (a) all obligations for the payment of principal, interest, penalties, fees or other liabilities for borrowed money (including guarantees and notes payable) and collection costs thereof, incurred or assumed, (b) any obligations to reimburse the issuer of any letter of credit, surety bond, debentures,

 

6


promissory notes, performance bond or other guarantee of contractual performance, in each case to the extent drawn or otherwise not contingent, (c) all indebtedness of third parties secured by an Encumbrance on property owned or acquired by such Person, (d) any obligation that, in accordance with Italian GAAP, would be required to be reflected as debt on the balance sheet of such Person, (e) liabilities in respect of any financial hedging arrangements, interest rate cap agreements, swap agreements or similar agreements, (f) liabilities under leases required to be capitalized on a balance sheet of such Person in accordance with Italian GAAP, (g) the deferred portion or installments of purchase price, and any amounts reserved for the payment of a contingent purchase price (including earn outs) in connection with the acquisition of any assets or business, and (h) all Indebtedness of others referred to in clauses (a) through (g) above guaranteed directly or indirectly in any manner by such Person, or in effect guaranteed directly or indirectly by such Person through an agreement to pay or purchase such Indebtedness, to advance or supply funds for the payment or purchase of such Indebtedness or otherwise to assure a creditor against loss, in each case including all accrued interest and prepayment penalties, if any.

Indemnifying Party ” has the meaning set forth in Section 7.3 .

Instrument ” has the meaning set forth in Section 2.8(c) .

Intellectual Property ” means all of the following in all jurisdictions throughout the world: (i) trademarks and service marks, trade dress, trade names and other indications of origin, applications or registrations or existing at common law in any jurisdiction pertaining to the foregoing and all goodwill associated therewith; (ii) inventions, discoveries, improvements, ideas, know-how, formulas, methodology, processes, technology, software (including password unprotected interpretive code or source code, object code, development documentation, programming tools, drawings, rules, specifications and data) and applications and patents in any jurisdiction pertaining to the foregoing, including re-issues, continuations, divisions, continuations-in-part, renewals or extensions; (iii) trade secrets, including models, methodologies, specifications, rules, procedures, processes and other confidential information and the right in any jurisdiction to limit the use or disclosure thereof; (iv) copyrights in writings, designs, software, mask works or other works, applications or registrations in any jurisdiction for the foregoing and all moral rights related thereto; (v) database rights; (vi) Internet Websites, domain names and applications and registrations pertaining thereto; (vii) all similar proprietary rights; (viii) books and records pertaining to the foregoing; and (ix) claims or causes of action arising out of or related to past, present or future infringement or misappropriation of the foregoing.

Knowledge ” of the Company or the Group Companies means the actual knowledge of Silvano Spinelli and Gabriella Camboni.

Leased Real Property ” has the meaning set forth in Section 3.5(c) .

MA Milestone ” has the meaning set forth in the definition of “MA Subsequent Payment Date” in Section 1.1 .

MA Subsequent Payment Amount ” has the meaning set forth in Section 2.4(c) .

 

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MA Subsequent Payment Date ” means the fifth (5th) Business Day following the date when the milestone payment from Servier (or its successors) associated with approval by the European Commission of the first Marketing Authorization for the first indication of the Development Compound as per section 8.4(b) of the Collaboration and License Agreement is received by the Company or its Affiliates or designees under the Collaboration and License Agreement (the receipt of such milestone payment being the “ MA Milestone ).”

Majority ” has the meaning set forth in Section 2.8(b) .

Material Adverse Effect ” shall mean any event, change, circumstance, effect, development or state of facts (whether specific to the applicable party or generally applicable to multiple parties), violation, inaccuracy or other matter that has had, or would reasonably be expected to have, individually or in the aggregate with other events a material adverse effect on (a) the financial condition, business, results of operations, assets, liabilities, or financial performance of the party making the representations and warranties, or (b) the ability of such party to consummate the transactions contemplated by this Agreement or to perform any of its obligations under this Agreement.

Material Contracts ” has the meaning set forth in Section 3.7(a) .

Milestone ” means any of the NDA Milestone, EMA Milestone, MA Milestone or Sales Milestone.

Most Recent Balance Sheet ” has the meaning set forth in Section 3.9 .

NDA Milestone ” has the meaning set forth in the definition of “NDA Subsequent Payment Date” in Section 1.1 .

NDA Subsequent Payment Amount ” has the meaning set forth in Section 2.4(a) .

NDA Subsequent Payment Date ” means the fifth (5th) Business Day following the date of receipt of the first New Drug Application approval from the FDA of the Development Compound in the United States, the obtaining of such New Drug Application approval from the FDA being the “ NDA Milestone .

Net Working Capital Adjustment Statement ” has the meaning set forth in Section 2.6(b) .

Net Working Capital Deficiency Amount ” has the meaning set forth in Section 2.6(b) .

Net Working Capital Excess Amount ” has the meaning set forth in Section 2.6(b) .

Net Working Capital Statement ” has the meaning set forth in Section 2.6(b) .

Neutral Arbitrator ” has the meaning set forth in Section 2.6(d) .

Non-Compete Agreements ” has the meaning set forth in Section 2.3(a)(vi).

 

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Ordinary Course of Business ” or “ Ordinary Course ” or any similar phrase means the ordinary course of the Group Companies’ business, consistent with the past practice of the Group Companies.

Ordinary Shares ” means ordinary shares, par value €1, of the Company.

Parties ” has the meaning set forth in the Preamble.

Per Share Price ” means $51.1615 per share of Buyer Common Stock, subject to adjustment after the Closing as appropriate to reflect any stock split, reverse stock split, stock dividend or similar transaction effected by Buyer.

Permits ” means all licenses, permits, franchises, approvals, authorizations, consents or orders of, or filings with, any Governmental Authority, whether non-U.S., federal, state or local, necessary for the conduct of, or relating to, the operation of the Group Companies’ business.

Permitted Encumbrances ” means (a) liens, taxes, assessments and other governmental charges, in each case, not yet due and payable or which are being contested in good faith by appropriate proceedings; (b) statutory, mechanics’, laborers’ and materialmen liens arising in the Ordinary Course of Business for sums not yet due; (c) statutory and contractual landlord liens under leases pursuant to which a Group Company is a lessee and not in default; (d) with regard to real property, any and all matters of record in the jurisdiction where the real property is located including restrictions, reservations, covenants, conditions, oil and gas leases and mineral severances; (e) with regard to real property, any easements, rights-of-way, building or use restrictions, prescriptive rights, encroachments, protrusions, rights and party walls, and liens for taxes, assessments, and other governmental charges, in each case, not yet due; (f) liens securing rental payments under capital lease arrangements to the extent they are imposed only upon the leased equipment; (g) pledges or deposits made in the Ordinary Course of Business which do not in the aggregate materially detract from the value of the related assets or properties or materially impair the use thereof in the operation of the Group Companies’ business; and (h) similar liens and encumbrances which are incurred in the Ordinary Course of Business and which do not in the aggregate materially detract from the value of the related assets or properties or materially impair the use thereof in the operation of the Group Companies’ business.

Permitted Transfer ” means (a) if such holder is an individual, a Transfer (subject to Applicable Law): (i) to any member of such holder’s immediate family or to a trust or other estate planning vehicle for the benefit of such holder or any member of such holder’s immediate family or (ii) upon the death of such holder, to such holder’s heirs, (b) if such holder is a partnership, limited liability company or similar entity, a Transfer (subject to Applicable Law): (i) pro rata to its partners or members of such holder, (ii) to an affiliated corporation, trust or other business entity under common control with such holder, or (iii) if such holder is a trust, to a beneficiary, (c) if such holder is a corporation or similar entity, a Transfer (subject to Applicable Law): (i) pro rata to its shareholders of such corporation or stakeholders of a similar entity or (ii) to its Affiliates, (d) if such holder is an investment management company (i.e. a società di gestione del risparmio ) acting on behalf of funds managed by it, a Transfer (subject to Applicable Law): (i) pro rata to the investors of the closed-end fund on behalf of which the

 

9


shares in the Company are held by the investment management company, (ii) to its shareholders or (iii) to its Affiliates, or (e) for each holder, a Transfer to an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act; provided , that , in the case of a Transfer pursuant to this clause (e), such Transfer shall be conditioned upon (x) the receipt by the Company, if requested by the Company, of a legal opinion from counsel reasonably acceptable to the Company to the effect that the proposed Transfer is exempt from the registration provisions of the Securities Act and (y) such Transfer will not result in an aggregate of more than one hundred (100) holders of the instrument being transferred; provided , further , that in each case of clauses (a) through (e) above, such Transfer shall only be permitted if, as a precondition to such Transfer, (1) the transferee agrees in writing, reasonably satisfactory in form and substance to Buyer, that the right(s) received by such transferee shall be bound by the terms of this Agreement and (2) such Transfer will not result in an aggregate of more than two hundred (200) holders of the instrument being transferred.

Person ” means any person or entity, whether an individual, trustee, corporation, partnership, limited partnership, limited liability company, trust, unincorporated organization, business association, firm, joint venture or Governmental Authority.

Pre-Closing Taxes ” means (a) all liability for Taxes of the Group Companies for any Tax period ending on or prior to the Closing Date and, with respect to a Tax period beginning before and ending after the Closing Date, the portion of any such Tax period ending on and including the Closing Date; (b) all liability for Taxes resulting by reason of any Group Company having been a member of any consolidated, combined or unitary group on or prior to the Closing Date; (c) all liability for Taxes of any other person pursuant to any contractual agreement entered into on or before the Closing Date; and (d) all liability for Taxes (other than as contemplated by Section 6.9(b) ) imposed on the Sellers in connection with the transactions contemplated by this Agreement. For purposes of this definition, where it is necessary to apportion Taxes between Buyer and the Sellers, such liability shall be apportioned between the period (or portion thereof) deemed to end at the close of business on the Closing Date, for which the Sellers shall be responsible, and the period (or portion thereof) deemed to begin at the beginning of the day following the Closing Date, for which Buyer shall be responsible, on the basis of an interim closing of the books or, in the case of non-income Taxes not susceptible to such apportionment, on the basis of the number of days elapsed in the period (or portion thereof) deemed to end at the close of business on the Closing Date and the period (or portion thereof) deemed to begin at the beginning of the day following the Closing Date, respectively.

Preferred Shares ” means all Series A Preferred Shares, par value €1, Series A2 Preferred Shares, par value €1, Series A3 Preferred Shares, par value €1, and Series A4 Preferred Shares, par value €1, of the Company.

Pro Rata Percentage ” has the meaning set forth in Section 2.3(c)(iv) .

Proceeding ” has the meaning set forth in Section 3.17 .

Registration Rights Agreement ” means a registration rights agreement governing the registration of the Share Consideration for resale in the form of Exhibit C attached hereto.

 

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Representative ” means, with respect to any Person, any officer, director, principal, attorney, agent, advisor, employee or other representative of such Person.

Resolution Period ” has the meaning set forth in Section 2.6(c) .

Retained Escrow Amount ” has the meaning set forth in Section 2.7(b) .

Sales Milestone ” has the meaning set forth in the definition of “Sales Subsequent Payment Date” in Section 1.1 .

Sales Subsequent Payment Amount ” has the meaning set forth in Section 2.4(d) .

Sales Subsequent Payment Date ” means the fifth (5th) Business Day following the date when the milestone payment from Servier (or its successors) is received by the Company or its Affiliates or designees under the Collaboration and License Agreement, when the aggregate net sales of the Development Compound in the Servier Licensed Territory first reaches the threshold of €500,000,000 in any four consecutive calendar quarters as per section 8.4(c) of the Collaboration and License Agreement, the receipt of such milestone payment being the “ Sales Milestone .”

SEC ” means the United States Securities and Exchange Commission.

Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

Seller Indemnified Parties ” has the meaning set forth in Section 7.2(a)(iii) .

Seller Released Claims ” has the meaning set forth in Section 6.11(b) .

Seller Released Obligations ” has the meaning set forth in Section 6.11(a) .

Seller Released Parties ” has the meaning set forth in Section 6.11(a) .

Sellers ” has the meaning set forth in the Preamble.

Sellers’ Representative ” has the meaning set forth in the Preamble and Section 2.8(a) .

Sellers’ Representative’s Costs ” has the meaning set forth in Section 2.8(e) .

Sellers’ Representative’s Fund ” means the Sellers’ Representative’s Fund Amount to be delivered to the Sellers’ Representative for the purpose of paying the expenses, if any, incurred by the Sellers’ Representative in connection with this Agreement.

Sellers’ Representative’s Fund Amount ” means $500,000.

 

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Serious Adverse Event ” means any adverse drug experience, including what are commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with or observed in conjunction with the use of a drug in humans, whether or not considered related to the use of that product, occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Servier ” means the Institut de Recherches Internationales Servier and Les Laboratoires Servier.

Servier Licensed Territory ” means all countries in the world, except Japan (and its territories and possessions), the People’s Republic of China and the United States of America (and their territories and possessions).

Severance Agreements ” means the agreements set forth on Schedule 1.1(b) .

Share Consideration ” means 3,528,044 shares of Buyer Common Stock.

Shares ” has the meaning set forth in the Recitals.

Specified Obligations ” has the meaning set forth in Section 6.11(a) .

Stockholder(s) ” means holders of Shares.

Subsequent Consideration ” means the sum, if any, of the NDA Subsequent Payment Amount, the EMA Subsequent Payment Amount, the MA Subsequent Payment Amount and the Sales Subsequent Payment Amount, it being understood between the Parties that such Subsequent Consideration is merely possible and are conditioned upon the occurrence of certain events as provided for under this Agreement.

Subsidiary ” when used with respect to any Party, shall mean any corporation or other organization, whether incorporated or unincorporated, at least a majority of the securities or other interests of which having by their terms ordinary voting power to elect a majority of the board of directors or others performing similar functions with respect to such corporation or other organization is directly or indirectly owned or controlled by such Party or by any one or more of its Subsidiaries, or by such Party and one or more of its Subsidiaries.

Target Net Working Capital ” means U.S. $0.

Tax ” (including with correlative meaning, the terms “ Taxes ” and “ Taxable ”) means (a) all taxes, duties, or similar governmental charges, levies, imposts, or withholdings (including net income, gross income, gross receipts, sales, use, ad valorem, transfer, franchise, profits, license, lease, service, service use, withholding, payroll, employment, excise, severance, stamp, occupation, premium, property, windfall profits, customs, duties or other taxes, duties, charges, levies, imposts, withholdings or charges of any kind whatsoever) whenever and by whatever Governmental Authority imposed, and whether of the United States or elsewhere, whether or not any such taxes, duties, charges, levies, imposts or withholdings are directly or

 

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primarily chargeable against or to the Group Companies, together with in any such case any interest, fines, penalties, surcharges and charges incidental or relating to the imposing of any of such Taxes and any additions to tax or additional amounts with respect thereto, (b) any liability for payment of amounts described in clause (a) above whether as a result of transferee liability, of being a member of an affiliated, consolidated, combined or unitary group for any period, or otherwise through operation of law, and (c) any liability for the payment of amounts described in clauses (a) or (b) as a result of any tax sharing, tax indemnity or tax allocation agreement or any other express or implied agreement to indemnify any other person.

Tax Return ” means any return, declaration, report, statement, information statement and other document required to be filed with respect to Taxes.

Transaction Consideration ” has the meaning set forth in Section 2.1 .

Transaction Expenses ” means fees and expenses of the Group Companies incident to this Agreement and the transactions contemplated hereby which are unpaid as of the Closing, including legal and accounting fees, investment banking fees, and related disbursements in connection with any of the foregoing, the amounts payable under the Non-Compete Agreements, one half of the aggregate amounts payable pursuant to the Severance Agreements, and the aggregate amounts payable pursuant to the Bonus Agreements and any other transaction bonus, discretionary bonus, “stay put” or similar compensatory payments and any tax gross-up payments (including any premiums and matching sums with respect thereto) payable to any current or former directors, officers, employees, shareholders or service providers to any of the Group Companies at or after the Closing as a result of the execution of this Agreement or the consummation of the transactions contemplated hereby, or at the discretion of the Group Companies.

Transfer ” means a direct or indirect transfer in any form, including a sale, assignment, license, conveyance, pledge, charge, mortgage, encumbrance, securitization, hypothecation or other disposition, or any purported severance or alienation of any beneficial interest (including the creation of any derivative or synthetic interest) or “beneficial ownership” (as determined pursuant to Rule 13d-3 under the Securities Exchange Act of 1934), or the act of so doing, as the context requires.

Working Capital Dispute Notice ” has the meaning set forth in Section 2.6(c) .

1.2. Other Terms . Other terms may be defined elsewhere in the text of this Agreement and, unless otherwise indicated, shall have such meaning indicated throughout this Agreement.

1.3. Interpretation . (a) In this Agreement, unless the context otherwise requires, references:

(i) to the Recitals, Articles, Sections, exhibits, schedules or Disclosure Schedule are to a Recital, Article or Section of, or exhibit, schedule or Disclosure Schedule to, this Agreement;

(ii) to any agreement (including this Agreement), contract, statute or regulation are to the agreement, contract, statute or regulation as amended, modified, supplemented or replaced from time to time, and to any section of any statute or regulation are to any successor to the section;

 

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(iii) to any Governmental Authority include any successor to that Governmental Authority; and

(iv) to this Agreement are to this Agreement and the exhibits and schedules to it, taken as a whole.

(b) The table of contents and headings contained herein are for reference purposes only and do not limit or otherwise affect any of the provisions of this Agreement.

(c) Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”

(d) Whenever the words “herein” or “hereunder” are used in this Agreement, they shall be deemed to refer to this Agreement as a whole and not to any specific Section, unless otherwise indicated.

(e) The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.

(f) The terms “dollars” and “$” shall mean dollars of the United States of America.

(g) The terms “Euro” and “€” shall mean the currency of the Institutions of the European Union.

ARTICLE II.

PURCHASE AND SALE

2.1. Purchase and Sale . Upon the terms and subject to the conditions set forth in this Agreement, at the Closing, Buyer shall purchase from each Seller, and each Seller shall sell, convey, transfer, assign and deliver to Buyer, free and clear of all Encumbrances, the Shares set forth opposite its name on Exhibit 2.3(c) in exchange for such Sellers’ share of the Share Consideration and the Estimated Cash Consideration, and, subject to Sections 2.4 , 2.6 , 2.7 and 2.8 , the Subsequent Consideration, the Escrow Amount, to the extent released to the Sellers, the Sellers’ Representative’s Fund Amount, to the extent released to the Sellers, and any amounts payable pursuant to Section 2.6(f) , in each case as specified on Exhibit 2.3(c) (together, in the aggregate, the “ Transaction Consideration ”). The obligation of Buyer to purchase from each Seller such Seller’s Shares at the Closing shall be subject to the simultaneous purchase by Buyer of all the Shares from all of the Sellers.

2.2. Closing of the Transactions Contemplated by this Agreement . The closing of the transactions contemplated hereby (the “ Closing ”) shall take place at the offices of Studio Legale Delfino e Associati, Willkie Farr & Gallagher LLP, Via Michele Barozzi, 2, 20122 Milan on the date hereof. All Closing transactions shall be deemed to take place simultaneously and no one of them shall be deemed to have occurred until all shall have occurred. The date on which the Closing occurs is referred to herein as the “ Closing Date .”

 

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2.3. Deliveries at the Closing .

(a) Deliveries by the Sellers . At the Closing, and as a condition to Buyer’s obligations hereunder, the Sellers shall deliver, or cause to be delivered (by the Sellers’ Representative or otherwise), to Buyer:

(i) certificate(s) representing the Shares, duly endorsed in favor of Buyer or accompanied by stock powers or any other proper instrument of assignment endorsed in favor of Buyer in proper form for transfer, in form and substance reasonably acceptable to Buyer;

(ii) counterparts, duly executed by the Sellers, to an agreement, in form and substance reasonably acceptable to Buyer, whereby the Parties acknowledge that the Shares endorsement carried out at the Closing does not give rise to any novation of this Agreement, pursuant to and for the effects of Articles 1230 and following of the Italian Civil Code, and that this Agreement remains, therefore, in full force upon the Shares endorsement;

(iii) a good standing certificate of the Company issued by the competent Italian bankruptcy court, dated no more than five (5) Business Days prior to the Closing Date;

(iv) counterparts to the Escrow Agreement duly executed by the Sellers’ Representative;

(v) counterparts to the Registration Rights Agreement duly executed by the Sellers;

(vi) counterparts to non-compete agreements in form and substance reasonably satisfactory to Buyer, duly executed by the Persons set forth on Exhibit 2.3(a)(vi) (the “ Non-Compete Agreements ”);

(vii) payoff letters in form and substance reasonably acceptable to Buyer with respect to the repayment, as contemplated hereby, of the Debt Payoff Amount, if any, together with the release of Encumbrances related thereto, if any;

(viii) invoices, receipts or other written confirmation with respect to all Transaction Expenses payable by or for the account of any of the Group Companies;

(ix) resignations in form and substance reasonably satisfactory to Buyer, duly executed by the directors of the Group Companies, in a text substantially in compliance with Exhibit 2.3(a)(ix) ;

(x) timely delivery of notices in form and substance reasonably acceptable to Buyer for the summoning on the Closing Date of the Stockholders’ meetings on the Closing Date for the release of the resigning directors (except for fraud, willful misconduct and gross negligence), the appointment of the directors of the Group Companies and for the amendments to the bylaws of the Group Companies;

 

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(xi) evidence satisfactory to Buyer of the approval of, or the termination or expiration of any required waiting periods (including any extension thereof) applicable to, this Agreement and the transactions contemplated hereby in accordance with the HSR Act;

(xii) evidence satisfactory to Buyer that all obligations of the Group Companies under the Letter Agreement, dated March 22, 2011, by and between the Company and Stifel, Nicolaus & Company, Incorporated, as amended March 5, 2013, have been extinguished;

(xiii) evidence satisfactory to Buyer that all obligations of the Group Companies with respect to the payment of all “premium” amounts in connection with the transactions contemplated hereby pursuant to the Investment and Shareholders’ Agreement, dated July 3, 2009, by and among the Company and the shareholders of the Company named therein, and the addenda thereto dated November 22, 2010 and March 21, 2012, to shareholders or employees of the Group Companies have been satisfied or waived; and

(xiv) all other documents, instruments and certificates specifically required by this Agreement to be delivered by the Sellers and the Company at or prior to the Closing.

(b) Deliveries by Buyer . At the Closing, and as a condition to the Sellers’ obligations hereunder, Buyer shall:

(i) deliver to the Escrow Agent, the Escrow Amount and counterparts to the Escrow Agreement duly executed by Buyer;

(ii) deliver to the Sellers’ Representative, the Sellers’ Representative’s Fund Amount;

(iii) deliver to the Sellers, counterparts, duly executed by Buyer, to an agreement, in form and substance reasonably acceptable to Buyer, whereby the Parties acknowledge that the Shares endorsement carried out at the Closing does not give rise to any novation of this Agreement, pursuant to and for the effects of Articles 1230 and following of the Italian Civil Code, and that this Agreement remains, therefore, in full force upon the Shares endorsement;

(iv) pay, or cause to be paid, on behalf of the Company, the amounts of any Indebtedness set forth on Exhibit 2.3(b)(iv) of the Company unpaid at the Closing (the “ Debt Payoff Amount ”);

(v) pay, or cause to be paid, on behalf of the Company, the amounts of any Transaction Expenses of the Company unpaid at the Closing;

 

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(vi) pay to each Seller, by wire transfer of immediately available funds, the portion of the Estimated Cash Consideration set forth on Exhibit 2.3(c) for such Seller;

(vii) deliver counterparts to the Registration Rights Agreement duly executed by Buyer;

(viii) deliver a release letter (including any waiver of actions according to Italian laws) (except for any fraud, gross negligence or willful misconduct) of the current directors of the Group Companies in the form attached hereto as Exhibit 2.3(b)(viii) ; and

(ix) deliver to each Seller the portion of the Share Consideration set forth on Exhibit 2.3(c) for such Seller.

(c) Transaction Consideration . Exhibit 2.3(c) hereof sets forth:

(i) the name of each Seller;

(ii) the portion of the Estimated Cash Consideration payable to each Seller;

(iii) the number of shares of the Share Consideration issuable to each Seller at the Closing in accordance with this Agreement;

(iv) the portion, expressed as a percentage (with respect to each Seller, their “ Pro Rata Percentage ”), of the Escrow Amount, if any, payable to each Seller in accordance with this Agreement and the Escrow Agreement;

(v) each Seller’s Pro Rata Percentage of the Sellers’ Representative’s Fund Amount remaining in the Sellers’ Representative’s Fund payable to each Seller upon termination of the Sellers’ Representative’s Fund in accordance with this Agreement;

(vi) the portion of the NDA Subsequent Payment Amount, if any, the EMA Subsequent Payment Amount, if any, the MA Subsequent Payment Amount, if any, and the Sales Subsequent Payment Amount, if any, payable to each Seller in accordance with this Agreement; and

(vii) the portion, expressed as a percentage, of any amounts payable pursuant to Section 2.6(f) .

2.4. Subsequent Payments .

(a) Upon the NDA Subsequent Payment Date, if any, Buyer shall deliver or cause to be delivered $65,000,000 (the “ NDA Subsequent Payment Amount ”) to the Sellers by wire transfer of readily available funds, each such Seller’s portion of the NDA Subsequent Payment Amount set forth on Exhibit 2.3(c) .

(b) Upon the EMA Subsequent Payment Date, if any, Buyer shall deliver or cause to be delivered €15,000,000 (the “ EMA Subsequent Payment Amount ”) to the Sellers by wire transfer of readily available funds, each such Seller’s portion of the EMA Subsequent Payment Amount set forth on Exhibit 2.3(c) .

 

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(c) Upon the MA Subsequent Payment Date, if any, Buyer shall deliver or cause to be delivered €45,000,000 (the “ MA Subsequent Payment Amount ”) to the Sellers by wire transfer of readily available funds, each such Seller’s portion of the MA Subsequent Payment Amount set forth on Exhibit 2.3(c) .

(d) Upon the Sales Subsequent Payment Date, if any, Buyer shall deliver or cause to be delivered €55,000,000 (the “ Sales Subsequent Payment Amount ”) to the Sellers by wire transfer of readily available funds, each such Seller’s portion of the Sales Subsequent Payment Amount set forth on Exhibit 2.3(c) .

(e) The right of each Seller to receive the NDA Subsequent Payment Amount, if any, the EMA Subsequent Payment Amount, if any, the MA Subsequent Payment Amount, if any, and the Sales Subsequent Payment Amount, if any, pursuant to Sections 2.4(a) , 2.4(b) , 2.4(c) and 2.4(d) may not be Transferred by the Sellers, except by Permitted Transfer.

(f) If (i) Buyer shall consolidate with or merge into or with any other entity, (ii) Buyer shall transfer all or substantially all of its properties or assets to any person, or (iii) the Company Transfers the right to receive payments from Servier under the Collaboration and License Agreement or transfers or assigns the Collaboration and License Agreement, then Buyer, the Group Companies and their Affiliates, as the case may be, shall cause the other party to such transaction to assume all of Buyer’s obligations under this Section 2.4; provided, that, in no event shall Buyer be relieved of its obligations under this Agreement, including this Section 2.4.

(g) For the avoidance of doubt, any payment directly by Servier of the MA Subsequent Payment Amount, EMA Subsequent Payment Amount and/or Sales Subsequent Payment Amount, if any, to Sellers shall reduce Buyer’s obligation, if any, to make the MA Subsequent Payment Amount, EMA Subsequent Payment Amount and/or Sales Subsequent Payment Amount, as applicable, in the amount of the payment made by Servier. In addition, for the purposes of the EMA Subsequent Payment Amount, the MA Subsequent Payment Amount and the Sales Subsequent Payment Amount, the Buyer shall be deemed to have “received” the milestone payment from Servier related to such amounts for the purposes hereof to the extent that the actual milestone payment sent by Servier to the Buyer of its Affiliates is less than the amount due hereunder (or under the Collaboration and License Agreement) because of a contractual agreement to net or offset payments to Buyer or its Affiliates.

(h) For the avoidance of doubt, all references to Sellers in this Section 2.4 shall refer to Sellers and their Permitted Transferees, to the extent a Permitted Transfer occurs.

2.5. Withholding Rights . Buyer acknowledges that it is not required to deduct or withhold any amount or Tax from the Transaction Consideration payable on the Closing Date under the Code, or any provision of United States federal, state or local, or any Italian, Tax law. Other than with respect to the matters acknowledged in the preceding sentence, Buyer shall be entitled to deduct and withhold from the Transaction Consideration otherwise payable pursuant to this Agreement such amounts as it is required to deduct and withhold with respect to the

 

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making of such payment under the Code, or any provision of United States federal, state or local, or any non-U.S., Tax law. To the extent that amounts are so withheld or paid over to or deposited with the relevant Governmental Authority by Buyer, such amounts shall be treated for all purposes of this Agreement as having been paid to the applicable holder of Shares in respect of which Buyer made such deduction and withholding.

2.6. Working Capital Adjustment .

(a) Not later than two (2) Business Days prior to the Closing Date, the Company shall have caused to be prepared and delivered to Buyer (i) a statement (the “ Estimated Net Working Capital Statement ”) setting forth the Company’s reasonable and good faith estimate of the Closing Date Net Working Capital and the components and calculations thereof and (ii) a statement (the “ Estimated Net Working Capital Adjustment Statement ”) setting forth the calculation of the amount by which the estimated Closing Date Net Working Capital as shown on the Estimated Net Working Capital Statement (the “ Estimated Net Working Capital ”) either (A) exceeds the Target Net Working Capital (such amount, the “ Estimated Net Working Capital Excess Amount ”) or (B) is less than the Target Net Working Capital (such amount, the “ Estimated Net Working Capital Deficiency Amount ”). In the event Buyer objects to the Estimated Net Working Capital set forth on the Estimated Net Working Capital Statement, Buyer and the Company shall negotiate in good faith to resolve such objections prior to the Closing.

(b) Within ninety (90) calendar days following the Closing Date, Buyer shall cause to be prepared and delivered to the Sellers’ Representative (i) a Closing Date Balance Sheet, (ii) a statement (the “ Net Working Capital Statement ”) setting forth its calculation of the Closing Date Net Working Capital and the components and calculations thereof, by reference to the Closing Date Balance Sheet, and (iii) a statement (the “ Net Working Capital Adjustment Statement ”) setting forth the calculation of the amount by which the Closing Date Net Working Capital as shown on the Net Working Capital Statement either (A) exceeds the Estimated Net Working Capital (as such amount may be adjusted below, the “ Net Working Capital Excess Amount ”) or (B) is less than the Estimated Net Working Capital (as such amount may be adjusted below, the “ Net Working Capital Deficiency Amount ”).

(c) After receipt of the Net Working Capital Statement and the Net Working Capital Adjustment Statement, the Sellers’ Representative shall have thirty (30) calendar days to review the Net Working Capital Statement and the Net Working Capital Adjustment Statement. Buyer shall give, or cause to be given, to the Sellers’ Representative reasonable access to all documents and records of the Group Companies used in their preparation. Not later than thirty (30) calendar days following the date of receipt of the Net Working Capital Statement and the Net Working Capital Adjustment Statement, the Sellers’ Representative shall provide Buyer with a written notice (a “ Working Capital Dispute Notice ”) listing those items, if any, to which the Sellers’ Representative takes exception, which notice shall also (i) specifically identify, and provide a reasonably detailed explanation of, the basis upon which the Sellers’ Representative has delivered such list, including, without limitation, the applicable provisions of this Agreement on which the dispute set forth in such Working Capital Dispute Notice is based, (ii) set forth the amount of Closing Date Net Working Capital that the Sellers’ Representative has calculated based on the information contained in the Net Working Capital Statement, and (iii) specifically

 

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identify the Sellers’ Representative’s proposed adjustment(s). Unless the Sellers’ Representative delivers the Working Capital Dispute Notice to Buyer setting forth the specific items disputed by the Sellers’ Representative on or prior to the thirtieth (30th) day following the Sellers’ Representative’s receipt of the Net Working Capital Statement and the Net Working Capital Adjustment Statement, the Sellers’ Representative on behalf of the Sellers shall be deemed to have accepted and agreed to the Net Working Capital Statement and the Net Working Capital Adjustment Statement and such statements (and the calculations contained therein) shall be final, binding and conclusive. If the Sellers’ Representative timely provides Buyer with a Working Capital Dispute Notice, the Sellers’ Representative and Buyer shall, within fifteen (15) days following receipt of such Working Capital Dispute Notice by Buyer (the “ Resolution Period ”), attempt to resolve their differences with respect to the items specified in the Working Capital Dispute Notice (the “ Disputed Items ”), and all other undisputed items (and all calculations relating thereto) shall be final, binding and conclusive. Any written resolution by the Sellers’ Representative and Buyer during the Resolution Period as to any Disputed Items shall be final, binding and conclusive.

(d) If the Sellers’ Representative and Buyer do not resolve all Disputed Items by written resolution by the end of the Resolution Period, then all Disputed Items remaining in dispute shall be submitted within fifteen (15) days following the expiration of the Resolution Period to Deloitte LLP (the “ Neutral Arbitrator ”); provided that if at such time either the Sellers’ Representative or Buyer shall discover a bona fide conflict with respect to the Neutral Arbitrator or the Neutral Arbitrator resigns or expressly states its refusal for any reason to resolve the Disputed Items in accordance with this Section 2.6 , the Parties shall submit the matter to another independent accounting firm of international reputation reasonably acceptable to both the Sellers’ Representative and Buyer to resolve the remaining matters in dispute, and such firm shall be the Neutral Arbitrator for all purposes of this Section 2.6(d) . The Neutral Arbitrator shall act as an arbitrator to determine only those Disputed Items remaining in dispute, consistent with this Section 2.6 , and shall request a statement from each of the Sellers’ Representative and Buyer regarding such remaining Disputed Items. The Neutral Arbitrator shall consider only those Disputed Items that the Sellers’ Representative on the one hand and Buyer on the other hand are unable to resolve. In resolving any disputed item, the Neutral Arbitrator may not assign a value to any item greater than the greatest value for such item claimed by any Party or less than the smallest value for such item claimed by any Party. The scope of the disputes to be arbitrated by the Neutral Arbitrator is limited to whether the preparation of the Net Working Capital Statement and the Net Working Capital Adjustment Statement were done in accordance with this Agreement, and whether there were mathematical errors in the preparation of the Net Working Capital Statement and the Net Working Capital Adjustment Statement, and the Neutral Arbitrator is not to make any other determination. All fees and expenses relating to the work, if any, to be performed by the Neutral Arbitrator shall be allocated between the Sellers’ Representative and Buyer in the same proportion that the aggregate amount of the Disputed Items so submitted to the Neutral Arbitrator that is unsuccessfully disputed by such Party (as finally determined by the Neutral Arbitrator) bears to the total amount of such Disputed Items so submitted by such Party. In addition, the Parties shall give the Neutral Arbitrator access to all documents, records and employees as reasonably necessary to perform its function as arbitrator. The Neutral Arbitrator shall deliver to the Sellers’ Representative and Buyer a written determination (such determination to include a work sheet

 

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setting forth all material calculations used in arriving at such determination and to be based solely on information provided to the Neutral Arbitrator by the Sellers’ Representative and Buyer) of the Disputed Items submitted to the Neutral Arbitrator within thirty (30) days following receipt of such Disputed Items (or as soon thereafter as practicable), which determination shall be final, binding and conclusive, and judgment may be entered on the award.

(e) The final, binding and conclusive Net Working Capital Statement and Net Working Capital Adjustment Statement, in each case, based either upon agreement by the Sellers’ Representative and Buyer, the written determination delivered by the Neutral Arbitrator in accordance with this Section 2.6 or the Sellers’ Representative’s failure to notify Buyer, in accordance with this Section 2.6 , of its objections to either the Net Working Capital Statement or the Net Working Capital Adjustment Statement (or any calculations contained therein) shall be the “ Conclusive Net Working Capital Statement ” and the “ Conclusive Net Working Capital Adjustment Statement, ” respectively. If either the Sellers’ Representative or Buyer fails to submit a statement regarding any Disputed Items submitted to the Neutral Arbitrator within the time determined by the Neutral Arbitrator or otherwise fails to give the Neutral Arbitrator access as reasonably requested, then the Neutral Arbitrator shall render a decision based solely on the evidence timely submitted and the access afforded to the Neutral Arbitrator by the Sellers’ Representative and Buyer.

(f)(i) Buyer shall pay an aggregate amount, if any, equal to the Net Working Capital Excess Amount, if any, set forth on the Conclusive Net Working Capital Adjustment Statement, which amount shall be paid to the Sellers or (ii) the Sellers’ Representative shall instruct the Escrow Agent to release to Buyer from the Escrow Account an amount equal to the Net Working Capital Deficiency Amount, if any, set forth on the Conclusive Net Working Capital Adjustment Statement. Any required payment under this Section 2.6(f) shall be paid on the third (3 rd ) Business Day following the determination of the Conclusive Net Working Capital Statement by (x) check or wire transfer of immediately available funds to each Seller of such Seller’s portion of such amount as set forth on Exhibit 2.3(c) (in the case of a Net Working Capital Excess Amount), or (y) wire transfer to such bank account or accounts as Buyer (in the case of a Net Working Capital Deficiency Amount) may specify. Any Net Working Capital Excess Amount shall be deemed to be an increase in the Transaction Consideration and any Net Working Capital Deficiency Amount shall be deemed to be a decrease in the Transaction Consideration for purposes of this Agreement. In the event the Escrow Amount is insufficient to satisfy any obligations to pay Buyer pursuant to this Section 2.6(f) , Buyer shall have the right (in addition to any other rights or remedies available to Buyer under law), but not the obligation, to withhold and off-set such amount from the Subsequent Consideration payments, if any.

2.7. Escrow Amount .

(a) Escrow Amount . At the Closing, $500,000 of cash and 185,687 shares of Buyer Common Stock (together, the “ Escrow Amount ”) shall be deposited into an escrow account (the “ Escrow Account ”) established with JP Morgan Chase Bank, National Association (the “ Escrow Agent ”) to be held by the Escrow Agent, pursuant to the terms of the escrow agreement attached as Exhibit B hereto (the “ Escrow Agreement ”), to serve as a source of payment for any amount due to Buyer for any claim for Damages for which any Buyer Indemnified Party is entitled to recovery pursuant to Article VII and amounts payable to Buyer

 

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pursuant to Section 2.6(f) . In connection with such deposit of the Escrow Amount into the Escrow Account with the Escrow Agent, each Seller shall be deemed to have received and deposited with the Escrow Agent such Seller’s pro-rata interest in the Escrow Account as determined as of the Closing by reference to Exhibit 2.3(c) , without any act of such Stockholder.

(b) Release of Escrow Amount . Promptly following the Escrow Expiration Date, the Escrow Agent shall distribute to the Sellers’ Representative, who shall proceed to distribute to the Sellers in accordance with the percentage amounts to which each Seller is entitled under this Agreement and the Escrow Agreement, as set forth on Exhibit 2.3(c) , the Escrow Amount then remaining in the Escrow Account (including accrued interests and other income) to such accounts designated by the Sellers minus the aggregate dollar amount of claims for Damages made by all Buyer Indemnified Parties pursuant to Article VII hereof (the “ Aggregate Outstanding Claims ”) which are then outstanding and unresolved (such amount of the retained Escrow Amount, as it may be further reduced after the Escrow Expiration Date by distributions to the Sellers’ Representative as set forth below and recoveries by the Buyer Indemnified Parties pursuant to Article VII hereof and the Escrow Agreement, the “ Retained Escrow Amount ”). For purposes of clarification, in the event that the amount of the Aggregate Outstanding Claims exceeds the remaining Escrow Amount, all the remaining Escrow Amount shall be retained in the Escrow Account as the Retained Escrow Amount. In the event and to the extent that after the Escrow Expiration Date any outstanding claim made by any Buyer Indemnified Party pursuant to Article VII hereof is resolved against such Buyer Indemnified Party, the Escrow Agent shall distribute to the Sellers’ Representative, who shall proceed to distribute to the Sellers in accordance with the percentage amounts to which each Seller is entitled under this Agreement and the Escrow Agreement, as set forth on Exhibit 2.3(c) , to such accounts designated by the Sellers an aggregate amount of the Retained Escrow Amount equal to the amount of the outstanding claim resolved against such Buyer Indemnified Party; provided , however , that such distribution shall only be made to the extent that the Retained Escrow Amount remaining after such distribution would be sufficient to cover the amount of the Aggregate Outstanding Claims that are still unresolved at such time. In the event and to the extent that after the Escrow Expiration Date any outstanding claim made by any Buyer Indemnified Party pursuant to Article VII hereof is resolved in favor of such Buyer Indemnified Party, such Buyer Indemnified Party shall be entitled to recover pursuant to Article VII hereof an amount equal to the amount of the outstanding claim resolved in favor of such Buyer Indemnified Party.

(c) Escrow Agent Fees and Expenses . Any administrative fees and expenses of the Escrow Agent shall be paid by Buyer. During the period in which the Escrow Amount (including any Retained Escrow Amount) is retained in the Escrow Account, all interest or other income earned from any investment of the Escrow Amount (the “ Escrow Earnings ”) shall be retained as additional amounts in the Escrow Account.

(d) Per Share Price . Any shares of Company Common Stock used to satisfy any claims made against the Escrow Account, or otherwise released from the Escrow Account, shall be valued at the Per Share Price.

 

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2.8. Sellers’ Representative .

(a) Appointment . As used in this Agreement, the term “ Sellers’ Representative ” shall mean Sofinnova Capital V FCPR, or any Person appointed as a successor Sellers’ Representative pursuant to Section 2.8(b) hereof. Sofinnova Capital V FCPR hereby accepts his, her or its appointment as the initial Sellers’ Representative. Effective upon the Closing, without any further action by any other Person, the Sellers’ Representative shall be appointed and constituted in respect of each Seller, as his, her or its agent, to act in his, her or its name, place and stead, as such Seller’s attorney-in-fact, as more fully set forth in Section 2.8(c) .

(b) Election and Replacement . From and after the Closing Date until the date when all obligations under this Agreement have been discharged (including all indemnification obligations under Article VII hereof), the Sellers who are entitled to receive in excess of 50% of the Transaction Consideration (the “ Majority ”), may, from time to time upon written notice to the Sellers’ Representative and Buyer, remove any Sellers’ Representative (including any appointed by Buyer as provided below) or appoint a new Sellers’ Representative to fill any vacancy created by the death, incapacitation, resignation or removal of any Sellers’ Representative. In the event of a vacancy, the Sellers will promptly appoint a successor Sellers’ Representative hereunder. A copy of any appointment by the Majority of any successor Sellers’ Representative shall be provided to Buyer promptly after it shall have been effected. Each successor Sellers’ Representative shall have all of the power, authority, rights and privileges conferred by this Agreement upon the original Sellers’ Representative, and the term “Sellers’ Representative” as used herein shall be deemed to include any successor Sellers’ Representative.

(c) Authority . Each Seller hereby irrevocably approves the constitution and appointment of, and hereby irrevocably constitutes and appoints the Sellers’ Representative with all of the rights, powers and obligations contemplated by this Section 2.8 as its sole, exclusive, true and lawful agent, representative and attorney-in-fact, with full power of substitutions, for and on behalf of such Seller, with respect to any and all matters arising out of this Agreement following the Closing and the Escrow Agreement, including for purposes of taking any action or omitting to take any action on behalf of such Seller. For this purpose each Seller hereby irrevocably undertakes to take any step or sign any document necessary to timely and fully implement the provisions set forth in this Section 2.8, also in order to formally grant to the Sellers’ Representative any power of attorney to validly bind the Sellers in the jurisdiction where the relevant obligation must be fulfilled under this Agreement. Without limiting the foregoing, the Sellers’ Representative shall be authorized, on behalf of the Sellers, (i) to discuss, negotiate, resolve and fully and finally settle on behalf of the Sellers any claims for indemnification hereof, including the authorization to comply with orders of courts with respect to any such claim for indemnification, to dispute the status of any unachieved Milestone, (ii) to review the Net Working Capital Statement and the Net Working Capital Adjustment Statement, deliver a Working Capital Dispute Notice and discuss, negotiate, resolve and fully and finally settle on behalf of the Sellers any disputes with respect to the Closing Date Net Working Capital pursuant to Section 2.6 hereof, (iii) to take any action, including litigating, defending or enforcing any actions and to make, deliver and sign any certificate, notice, consent or instrument required or permitted to be made or delivered under this Agreement or under the documents referred to in this Agreement (an “ Instrument ”) which the Sellers’ Representative determines in his or her discretion to be necessary, appropriate or desirable, and, in connection therewith ( provided ,

 

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however , if any individual Seller is named in such litigation, the Seller shall have the right to tender defense), (iv) to hire or retain, at the sole expense of the Sellers, such counsel, investment bankers, accountants, representatives and other professional advisors as he, she or it determines in his, her or its sole and absolute discretion to be necessary, advisable or appropriate in order to carry out and perform his or her rights and obligations hereunder, (v) to take any action for the benefit of the Sellers directly or indirectly connected to the provisions of this Agreement, including receiving any portion of the Escrow Amount and distributing to the Sellers the amounts to which each Seller is entitled under this Agreement and the Escrow Agreement, and (vi) to receive all documents, certificates and notices and make all determinations on behalf of the Sellers required under this Agreement. A decision, act, consent or instruction of the Sellers’ Representative shall constitute a decision of the Sellers and shall be final, binding and conclusive upon the Sellers, as the case may be. Any Party receiving an Instrument from the Sellers’ Representative shall have the right to rely in good faith upon such Instrument and to act in accordance with the Instrument without independent investigation. Buyer shall be entitled to disregard any notices or communications given or made by the Sellers unless given or made through the Sellers’ Representative. The Sellers’ Representative shall promptly, and in any event within five (5) Business Days, provide written notice to each Seller of any action taken on behalf of the Sellers by the Sellers’ Representative pursuant to the authority delegated to the Sellers’ Representative under this Section 2.8 .

(d) No Liability of the Sellers’ Representative or Buyer . Neither the Sellers’ Representative (nor any of the directors, officers, agents or employees of the Sellers’ Representative, if applicable) shall be liable to any Seller or any other Person for any error of judgment, or any action taken, suffered or omitted to be taken, under this Agreement, except in the case of the Sellers’ Representative’s fraud, gross negligence or willful misconduct. The Sellers’ Representative may consult with legal counsel, independent public accountants and other experts selected by the Sellers’ Representative and shall not be liable to any Seller for any action taken or omitted to be taken in good faith in accordance with the advice of such counsel, accountants or experts. As to any matters not expressly provided for in this Agreement, the Sellers’ Representative shall not be required to exercise any discretion or take any action. Buyer (and the Group Companies) shall have no liability to any of the Sellers or otherwise arising out of the acts or omissions of the Sellers’ Representative or any disputes among the Sellers or between the Sellers and the Sellers’ Representative. Buyer may rely entirely on its dealings with, and notices to and from, the Sellers’ Representative to satisfy any obligations it might have under this Agreement or otherwise to the Sellers.

(e) Indemnity; Costs and Expenses . Each Seller shall, only to the extent of and in proportion to the portion of the Transaction Consideration received by such Seller, indemnify and defend the Sellers’ Representative and hold the Sellers’ Representative harmless against any loss, damage, cost, liability or expense incurred without fraud, gross negligence or willful misconduct by the Sellers’ Representative and arising out of or in connection with the acceptance, performance or administration of the Sellers’ Representative’s duties under this Agreement. Any liabilities, losses, penalties, fines, claims, damages, out-of-pocket costs or expenses incurred by or reasonably expected to be incurred by the Sellers’ Representative in connection with the acceptance, performance and administration of his or her duties as the Sellers’ Representative pursuant to this Agreement (including the hiring of legal counsel, accountants or auditors and other advisors pursuant to the terms of this Agreement but excluding

 

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any of the foregoing arising out of the Sellers’ Representative’s fraud, gross negligence or willful misconduct) and all fees payable hereunder to the Sellers’ Representative by the Sellers (“ Sellers’ Representative’s Costs ”), shall be paid as follows: (i) first by recourse to the Sellers’ Representative’s Fund; (ii) if such amounts are insufficient to pay such Sellers’ Representative’s Costs, then by recourse to the Subsequent Consideration that becomes payable to the Sellers; and (iii) if such amounts are insufficient to pay such Sellers’ Representative’s Costs, then by recourse directly to the Sellers (in proportion to the pro rata portion of the Transaction Consideration otherwise to be received by such Sellers).

(f) Access to Information . If requested by Seller’s Representative, Buyer shall provide to the Sellers’ Representative on a semi-annual basis a written report concerning the status of the Development Product, including any unachieved Milestones. Buyer shall promptly (but no later than five (5) Business Days following the achievement of a Milestone) notify the Sellers’ Representative of the achievement of any Milestone. At the request of the Sellers’ Representative, upon reasonable notice and at a reasonable time and location, the Sellers’ Representative shall be entitled to ask, and have answered, reasonable questions about the status of the Development Product. The Sellers’ Representative covenants and agrees to keep secret and retain in strictest confidence, and shall not furnish, make available or disclose to any third party (other than the Sellers) or use for the Sellers’ Representative’s own benefit or the benefit of any third party, any Confidential Information, unless such information (i) was or becomes available to the public from a source other than the Sellers’ Representative or any Affiliate of the Sellers’ Representative, (ii) is requested to be disclosed by a Governmental Authority or required by Applicable Law or legal process (in which case the Sellers’ Representative shall, to the extent reasonably practicable and legally permissible, provide Buyer with advance notice of such required or requested disclosure, shall use commercially reasonable efforts (at Buyer’s sole cost and expense) to resist such disclosure, and, at the request of Buyer, shall cooperate with Buyer, at Buyer’s sole cost and expense, to limit or prevent such disclosure), or (iii) becomes available to the Sellers’ Representative after the date hereof on a non-confidential basis from a source other than the Group Companies, provided, that that such other source is not known by the Sellers’ Representative to be bound by a confidentiality agreement with or other obligation of confidentiality to Buyer or any of its Affiliates with respect to such information. Buyer shall not provide Sellers’ Representative with any material non-public information without first obtaining Sellers’ Representative’s prior written consent that it wishes to receive such material non-public information. Notwithstanding anything herein to the contrary, Sellers’ Representative shall not be permitted to furnish, make available or disclose confidential information received pursuant to this Section 2.8(f) to any Person (other than to the Sellers (but excluding any assignee or transferee of any Seller)) reasonably determined by Buyer to be a competitor of Buyer with respect to the Development Product.

(g) Dispute Resolution .

(i) In the event that the Sellers’ Representative shall dispute the status of any unachieved Milestone or a request for indemnification or setoff under this Agreement, then the Sellers’ Representative shall provide written notice to Buyer (the “ Dispute Notice ”) specifying the amount disputed and the basis for the dispute. Buyer and the Sellers’ Representative shall thereafter attempt to resolve the dispute as set forth in this Section 2.8(g) .

 

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(ii) The Sellers and Buyer shall attempt to resolve any dispute arising out of or relating to this Agreement promptly by negotiation in good faith between an agent chosen for the Sellers by the Sellers’ Representative (who may be the Sellers’ Representative) and an executive officer of Buyer who has authority to settle the dispute. Each Party shall give the other Party involved written notice of any dispute not resolved in the Ordinary Course of Business. Within seven (7) days following delivery of such notice, the Party receiving notice shall submit to the other a written response thereto. The notice and the response shall include: (i) a statement of each Party’s position(s) regarding the matter(s) in dispute and a summary of arguments in support thereof, and (ii) the name and title of the executive officer who shall represent Buyer and any other Person who shall accompany that executive officer, in the case of Buyer, or the name of the agent who shall represent the Sellers and any other Person who shall accompany that agent, in the case of the Sellers.

(iii) Within fourteen (14) days following delivery of the notice, the designated agent chosen by the Sellers’ Representative and the designated executive officer of Buyer shall meet at a mutually acceptable time and place, and thereafter, as often as they reasonably deem necessary, to attempt to resolve the dispute. All reasonable requests for information made by one Party to the other shall be honored in a timely fashion. All negotiations conducted pursuant to this Section 2.8(f) (and any of the Parties’ submissions in contemplation hereof) shall be kept confidential by the Parties and shall be treated by the Parties and their representatives as compromise and settlement negotiations under the Federal Rules of Evidence and any similar state rules.

(iv) In the event that the Sellers and Buyer are unable to resolve any dispute arising out of this Agreement in accordance with provisions (1), (2) and (3) of this Section 2.8(g) within six months of delivery of any Dispute Notice, Buyer and the Sellers shall submit such dispute for final adjudication in accordance with Section 8.13 .

ARTICLE III.

REPRESENTATIONS AND WARRANTIES OF THE COMPANY

As a material inducement to Buyer to enter into this Agreement, except as disclosed in the disclosure schedule delivered to Buyer by the Company and the Sellers concurrently herewith (the “ Disclosure Schedule ”) (it being understood that the Disclosure Schedule shall be arranged in sections corresponding to the sections contained in this Agreement, and the disclosures in any section of the Disclosure Schedule shall qualify the representations in the corresponding section of this Article III and shall be deemed made in any other section or sections of the Disclosure Schedule to the extent the relevance of such disclosures is readily apparent from the text of such disclosure), the Company hereby makes the following representations and warranties to Buyer as of the date hereof and as of the Closing Date.

3.1. Organization . Each Group Company is a corporation duly organized and validly existing and in good standing under the laws of the country of Italy with full corporate power and corporate authority to conduct its business as it is presently being conducted, to own, lease or operate, as applicable, its assets and properties and to perform all of its obligations under its contracts. Each Group Company is duly qualified to do business as a foreign corporation and is

 

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in good standing in each jurisdiction where the character of its properties owned, leased or operated or the nature of its activities make such qualification necessary, except where the failure to be so qualified or in good standing would not have a Material Adverse Effect on any Group Company. Copies of the deed of incorporation and current bylaws of each Group Company, which incorporate all amendments thereto, have heretofore been delivered to Buyer and are accurate and complete as of the date hereof. No Group Company is in violation of its deed of incorporation or bylaws.

3.2. Subsidiaries . Except for the Company Subsidiary, the Company does not own or control, directly or indirectly, or hold any rights to acquire, any capital stock or any other securities, interests or investments (other than investments that constitute cash or cash equivalents) in any other corporation, partnership, trust, joint venture, association, or other Person.

3.3. Authorization . The Company has all requisite power and authority, and has taken all action necessary, to execute, deliver and perform this Agreement, to consummate the transactions contemplated hereby and to perform its obligations hereunder. The execution and delivery of this Agreement and the consummation by the Company of the transactions contemplated hereby have been duly approved by the board of directors or other competent body of the Company. No other proceeding on the part of the Group Companies is necessary to authorize this Agreement and the transactions contemplated hereby. This Agreement has been duly executed and delivered by the Company and is the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws affecting creditors’ rights generally and except insofar as the availability of equitable remedies may be limited by Applicable Law.

3.4. Capitalization .

(a) Schedule 3.4(a) sets forth the name of each Person holding any equity securities of the Company and the type and amount of equity securities held by such Person. The authorized capital stock of the Company consists of 122,900 Ordinary Shares and 1,121,444 Preferred Shares. The Company has authorized four series of Preferred Shares, which include 675,536 Series A Preferred Shares, 108,185 Series A2 Preferred Shares, 200,843 Series A3 Preferred Shares and 136,880 Series A4 Preferred Shares. As of the date of this Agreement, there are issued and outstanding 122,900 Ordinary Shares, 675,536 Series A Preferred Shares, 108,185 Series A2 Preferred Shares, 200,843 Series A3 Preferred Shares and 136,880 Series A4 Preferred Shares. All of the issued and outstanding shares of capital stock of the Company are duly authorized, validly issued, fully paid and non-assessable. No claim has been made or threatened to the Company asserting that any Person other than a Person listed on Schedule 3.4(a) is the holder or beneficial owner of, or has the right to acquire beneficial ownership of, any securities of, or any other voting, equity or ownership interest in the Company. There are (i) no accrued and unpaid dividends on any of the Shares and (ii) no commitments to issue additional securities.

 

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(b) Other than those set forth in Section 3.4(a) , there are no (i) shares of capital stock or other securities of the Company outstanding, (ii) options, warrants, agreements, convertible, exercisable or exchangeable securities of the Company, (iii) other commitments pursuant to which the Company is or may become obligated to issue, sell, Transfer, purchase, return or redeem or otherwise acquire shares or other securities of the Company or to provide funds to, make an investment in, or contribute capital to, any Person, (iv) securities of the Company reserved for issuance for any purpose, (v) agreements pursuant to which registration rights in the shares of the Company have been granted, (vi) shareholders agreements, whether written or verbal, among any current or former Stockholders of the Company, (vii) statutory or contractual preemptive rights or rights of first refusal with respect to shares of capital stock or other securities of the Company, or (viii) stock appreciation rights, security-based performance units, “phantom” stock, profit participation or other similar rights or agreements pertaining to the Company.

(c) The Company has not violated any applicable securities laws in connection with the offer, sale or issuance of any of its capital stock. To the Knowledge of the Company, there are no agreements with respect to the voting or Transfer of the capital stock of the Company.

(d) The Company holds all of the securities of the Company Subsidiary. The authorized corporate capital of the Company Subsidiary consists of €90,000. As of the date of this Agreement, the Company Subsidiary has issued and paid corporate capital of €90,000. All of the issued and outstanding units of the Company Subsidiary are duly authorized, validly issued, fully paid and non-assessable. No claim has been made or threatened to the Company Subsidiary asserting that any Person other than the Company is the holder or beneficial owner of, or has the right to acquire beneficial ownership of, any unit of, or any other voting, equity or ownership interest in, the Company. There are (i) no accrued and unpaid dividends on any of the issued and outstanding units of the Company Subsidiary and (ii) no commitments to issue additional securities of the Company Subsidiary.

(e) There are no (i) securities of the Company Subsidiary outstanding other than those set forth in Section 3.4(d) , (ii) options, warrants, agreements, convertible, exercisable or exchangeable securities of the Company Subsidiary, (iii) other commitments pursuant to which the Company Subsidiary is or may become obligated to issue, sell, Transfer, purchase, return or redeem or otherwise acquire securities of the Company Subsidiary or to provide funds to, make an investment in, or contribute capital to, any Person, (iv) securities of the Company Subsidiary reserved for issuance for any purpose, (v) agreements pursuant to which registration rights in securities of the Company Subsidiary have been granted, (vi) securityholders agreements, whether written or verbal, among any current or former securityholders of the Company Subsidiary, (vii) statutory or contractual preemptive rights or rights of first refusal with respect to securities of the Company Subsidiary, or (viii) unit appreciation rights, security-based performance units, “phantom” units, profit participation or other similar rights or agreements pertaining to the Company Subsidiary.

(f) The Company Subsidiary has not violated any applicable securities laws in connection with the offer, sale or issuance of any of its securities. There are no agreements with respect to the voting or Transfer of the securities of the Company Subsidiary or with respect to any other aspect of the Company Subsidiary’s affairs.

 

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3.5. Title to Properties and Assets .

(a) Each Group Company has good and valid title to or, in the case of leased properties or properties held under license, a good and valid leasehold or license interest in, all of its material properties and assets. Each Group Company holds title to each material property and asset which it purports to own, free and clear of any Encumbrances other than Permitted Encumbrances. For the avoidance of doubt, the foregoing representations shall not apply to Intellectual Property, the applicable representations for which are addressed in Section 3.19 .

(b) All of the tangible assets of the Group Companies are in all material respects in reasonably serviceable operating condition and repair and are adequate for the conduct of their business in substantially the same manner as it has heretofore been conducted.

(c) Schedule 3.5(c) sets forth a true and complete list of all real property leased by the Group Companies (collectively, the “ Leased Real Property ”), including the lessor, lessee, location of, and a brief description of the nature of the activities conducted on, such Leased Real Property. The Group Companies have a valid leasehold interest in the Leased Real Property, free and clear of all Encumbrances, except Permitted Encumbrances. No Person other than the Group Companies has any right to use, occupy or lease all or any portion of the Leased Real Property.

(d) The Group Companies do not own, and never have owned, any real property.

3.6. Absence of Certain Activities or Changes . Since September 30, 2013, each Group Company has conducted its operations in the Ordinary Course of Business and (x) there has been no Material Adverse Effect on the Group Companies; or (y) none of the following actions have occurred with respect to any Group Company:

(a) the adoption of a plan of complete or partial liquidation or dissolution;

(b) the making of any loans, advances or capital contributions to, or investments in, any other Person;

(c) except as required by Italian GAAP, the making of any material change in its methods or principles of accounting since the date of the last audited Financial Statements;

(d) the making or changing of any material election, the changing of an annual accounting period, the adoption or changing of any material accounting method, the filing of any material amended Tax Return, the entering into of any closing agreement, the settling of any material Tax claim or assessment relating to the Group Company, or the consenting to of any extension or waiver of the limitation period applicable to any material Tax claim or assessment relating to the Group Company, if such election, adoption, change, amendment, agreement, settlement, surrender, consent or other action would have the effect of increasing the Tax liability of the Group Company for any period ending after the Closing Date;

(e) the revaluing of any of its assets other than in the Ordinary Course of Business;

 

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(f) the incurring of any Indebtedness for borrowed money or guaranteeing any such Indebtedness of another Person, the issuing or selling of any debt securities, warrants, calls or other rights to acquire any debt securities of the Group Company, the guaranteeing of any debt securities of another Person, the entering into of any “keep well” or other agreement to maintain any financial statement condition of any other Person (other than any wholly-owned Subsidiary of it) or entering into of any arrangement having the economic effect of any of the foregoing, other than in connection with the financing of Ordinary Course trade payables;

(g) the making of any capital expenditure exceeding $50,000 individually or $100,000 in the aggregate except for the Transaction Expenses;

(h) the acquisition (by way of merger, consolidation or business combination) or disposal of, in any form, any equity or voting interest in or any assets of any business or any Person or division thereof or the acquisition, disposition, sale or lease (as lessor or lessee) of any assets, securities or businesses;

(i) the waiving, releasing, assignment, settlement or compromise of any dispute, claim, suit, action or proceeding; or

(j) except as to the residual portion of the dividends on the 2012 financial year profit as approved at the 2013 annual general meeting of the Company, the declaring or setting aside or paying of any dividends on or the making of any other distributions (whether in stock, equity securities or property) in respect of any security of the Group Company.

3.7. Material Contracts .

(a) All agreements, contracts, leases, licenses, instruments, commitments and other obligations to which any Group Company is a party or by which it is bound that: (i) are material to the conduct and operations of its business and its properties, (ii) require any Group Company to provide in-kind consideration, (iii) contain covenants (A) to indemnify or hold harmless any Person or (B) not to (or otherwise restricting or limiting any Group Company’s ability to) compete in any line of business or geographical area, including any covenant not to compete with respect to the manufacture, marketing, distribution or sale of any product or product line, (iv) involve real property, (v) involve a joint venture, partnership, or limited liability company relationship, (vi) govern or relate to Indebtedness, including guarantees for money borrowed by others, (vii) obligate any Group Company to develop any product or technology, (viii) relate to the acquisition or disposition of any material assets, (ix) relate to any rights or obligations to undertake the development or commercialization of any pharmaceutical product, (x) require payments by any Group Company in excess of $50,000 per annum, (xi) contain a “change of control” or similar provision (other than any Benefit Plan), (xii) relate to the Development Products or any related products or the Development Compound, (xiii) are required to be set forth on Schedule 3.19(b) , (xiv) require capital expenditures or the acquisition or construction of any fixed asset which requires aggregate future payments in excess of $250,000, (xv) are not terminable upon ninety or fewer days notice without penalty or additional liabilities, or (xvi) grant any exclusive marketing, distribution or other similar rights (including “most favored nation” status) (collectively, the “ Material Contracts ”) are listed on Schedule 3.7(a) , and true, correct and complete copies of such agreements, contracts, leases, licenses, instruments, commitments, Indebtedness, liabilities and other obligations and any amendments or supplements thereto have been provided to Buyer.

 

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(b) All of the Material Contracts are valid, binding, in full force and effect and enforceable against the Group Companies, and to the Knowledge of the Company, the other parties thereto, each in accordance with their terms, except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws affecting enforcement of creditors’ rights generally and except insofar as the availability of equitable remedies may be limited by Applicable Law. The Group Companies are not in Default under any Material Contract and no event has occurred that with the passage of time or the giving of notice or both would give rise to a right of termination or acceleration. To the Knowledge of the Company, no other party is in Default under such Material Contracts and, to the Knowledge of the Company, no event has occurred and no condition or state of facts exists which, with the passage of time or the giving of notice or both, would constitute such a Default or give rise to a right of termination or acceleration and no written notice of any claim of Default or exercise of any right of termination or acceleration has been given to any Group Company. No Group Company is currently paying liquidated damages in lieu of performance under any Material Contract.

(c) With respect to the Collaboration and License Agreement, the Company has taken, or caused to be taken, each of the ADBK Actions (as such term is defined in the Collaboration and License Agreement).

(d) No Group Company is required to make any payment based upon or arising out of any provision of the Collaboration and License Agreement (or any proceeds received pursuant thereto), except for the payments set forth therein and in the Group Companies’ agreements with Advenchen Laboratories, LLC.

3.8. Compliance with Other Instruments . The execution, delivery and performance of and compliance with this Agreement and the consummation of the transactions contemplated hereby will not (a) result in a violation of, or be in conflict with or constitute, with or without the passage of time or the giving of notice or both, either a violation of, or conflict with the deed of incorporation or bylaws of any Group Company or, assuming the consents and approvals referred to in Section 3.16 are duly obtained, a violation of, or conflict with any Applicable Laws or Court Orders applicable to any Group Company or (b) violate, conflict with, result in any breach of, constitute a Default under, or give to others any rights of termination, renegotiation or acceleration, or result in the creation of any Encumbrance (other than a Permitted Encumbrance) upon any of the properties or assets of any Group Company, any contract or permit to which any Group Company is a party or by which any of such properties or assets are bound or affected, except (in the case of this clause (b) only) for any such violation, conflict, breach or Default which would not have a Material Adverse Effect on the Group Companies.

3.9. Financial Statements . Attached to Schedule 3.9 are (a) copies of the audited financial statements of the Company as of December 31, 2010, December 31, 2011 and December 31, 2012 and notes thereto accompanied by the reports thereon of KPMG, and (b) copies of the unaudited consolidated financial statements of the Group Companies as of September 30, 2013 and notes thereto (the balance sheet contained therein, the “ Most Recent

 

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Balance Sheet ”) (all the financial statements referred to in clauses (a) and (b) above being hereinafter collectively referred to as the “ Financial Statements ”). The Financial Statements, including the notes thereto, (i) were prepared in accordance with Italian GAAP applied on a consistent basis throughout the periods covered thereby and (ii) present fairly in all material respects the financial position, results of operations and changes in financial position of the Group Companies as of such dates and for the periods then ended (subject, in the case of the unaudited interim Financial Statements described in clause (b) above, to normal year-end audit adjustments consistent with prior periods that are not material in the aggregate).

3.10. Liabilities . The Group Companies have no liabilities of any nature whether known, unknown, and whether accrued, absolute, contingent, matured, unmatured or other, including “off balance sheet” liabilities, that, individually or in the aggregate, would reasonably be expected to be material to the Group Companies, taken as a whole, which are not shown or provided for on the Most Recent Balance Sheet other than (i) liabilities that have been incurred or accrued in the Ordinary Course of Business since the date of the Most Recent Balance Sheet, and (ii) liabilities incurred as a result of the execution, delivery or performance of this Agreement or as expressly permitted pursuant to the terms of this Agreement.

3.11. Taxes .

(a) The Group Companies have timely filed all Tax Returns they are required to file. Such Tax Returns are accurate, complete and correct in all material respects.

(b) The Group Companies have timely paid all Taxes required to be paid (whether or not shown as due on any Tax Returns and have adequately reserved in accordance with Italian GAAP in the Most Recent Balance Sheet for all Taxes (whether or not shown on any Tax Return) that have accrued but are not yet due or payable as of the balance sheet date.

(c)

(i) No written claim has been made by any taxing authority in any jurisdiction where the Group Companies do not file Tax Returns that it is or may be subject to Tax by that jurisdiction and the Group Companies have no Knowledge that any such claim is being contemplated.

(ii) No extensions or waivers of statutes of limitations with respect to the Tax Returns have been given by or requested from the Group Companies.

(iii) No written claim for assessment or collection of Taxes is presently being asserted against any Group Company, and there is no presently pending audit examination, refund claim, litigation, proceeding, proposed adjustment or matter in controversy with respect to any Taxes of or with respect to any Group Company, and the Group Companies have no Knowledge that any such action or proceeding is being contemplated.

(d) All deficiencies asserted or assessments made against the Group Companies as a result of any examinations by any taxing authority have been fully paid.

 

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(e) There are no Encumbrances for Taxes (other than for current Taxes not yet due and payable) upon the assets of the Group Companies.

(f) No Group Company is party to or bound by any tax indemnity, tax sharing, tax allocation or similar agreement.

(g) No Group Company is party to or bound by any closing agreement, offer in compromise or other agreement with any taxing authority.

(h)(i) No Group Company has ever been a member of an affiliated group of corporations, within the meaning of Section 1504 of the Code (or any predecessor provision or comparable provision of state, local or non-U.S. law), or a member of a combined, consolidated or unitary group for state, local or non-U.S. Tax purposes, other than the group of which the Company is the common parent;

(ii) No Group Company has liability for Taxes of any person (other than the Group Companies) under Treasury Regulation Section 1.1502-6 (or any corresponding provision of state, local or non-U.S. income Tax law), as transferee or successor, by contract, or otherwise; and

(iii) No Group Company has engaged in a transaction that constitutes a “reportable transaction”, as such term is defined in Treasury Regulation Section 1.6011-4(b)(1), or a transaction that constitutes a “listed transaction”, as such term is defined in Treasury Regulation Section 1.6011-4(b)(2).

(i) No Group Company has ever been a “distributing corporation” or a “controlled corporation” in connection with a distribution described in Section 355 of the Code.

(j) The Group Companies have withheld and paid, when due, all Taxes required to be withheld in connection with any amounts paid or owing to any employee, creditor, shareholder, independent contractor or other third party.

(k) There is no action, suit, proceeding, investigation, audit or claim now pending against, or with respect to, any Group Company in respect of any Tax or assessment, nor is any claim for additional Tax or assessment asserted by any Tax authority.

3.12. Environmental Matters . There have been by the Group Companies no disposals, releases or threatened releases of Hazardous Materials (as defined below) on, from or under the Leased Real Property that could be reasonably likely to form the basis of an Environmental Claim against any Group Company, (b) there are no Environmental Claims pending or, to the Knowledge of the Company, threatened against any Group Company and (c) no Group Company is subject to any agreement, order, judgment, decree, letter or memorandum by or with any Governmental Authority or third party imposing any liability or obligation under any Environmental Law. The Group Companies have no Knowledge of any presence, disposals, releases or threatened releases of Hazardous Materials on, from or under any of the Leased Real Property, which may have occurred prior to any Group Company having taken possession of any of the Leased Real Property. For the purposes of this Section 3.12 , “ Hazardous Materials

 

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shall mean any hazardous substance, hazardous waste, contaminant, pollutant, toxic substance, toxic chemical, hazardous material, hazardous chemical or petroleum and its fractions (as such terms are defined by all Applicable Laws relating to pollution, to the protection of the environment or to natural resources (collectively referred to herein as the “ Environmental Laws ”)).

3.13. Employee Benefits .

(a) Schedule 3.13(a) lists as of the date hereof a true and complete list of all bonus, pension, stock option, stock purchase, benefit, severance, insurance, incentive, deferred compensation and other similar fringe or employee benefit plans, funds, programs, arrangements or payroll practices, in each of the foregoing cases which cover, are maintained for the benefit of, or relate to any or all current employees of any Group Companies, including the severance payment “ Trattamento di Fine Rapporto ” and any mandatory or state sponsored Benefit Plans, pensions, funds, programs or arrangements (each a “ Benefit Plan ” and, collectively, the “ Benefit Plans ”). With respect to each Benefit Plan, the Sellers have provided the Buyer, to the extent applicable, with true and complete copies of all relevant plan documents.

(b) Each of the Benefit Plans, and the administration thereof, is, and has been, in compliance with the requirements provided by any Applicable Law. Other than routine claims for benefit, there is no material claim or proceeding (including any audit or investigation) pending or, to the Knowledge of the Company, threatened, involving any Benefit Plan or any Governmental Authority.

(c) With respect to the Benefit Plans, all required contributions for all periods ending before the Closing Date have been made in compliance with Applicable Law. As of the Closing Date none of the Benefit Plans will have unfunded benefit liabilities.

(d) With respect to each Benefit Plan (i) no transaction prohibited by any Applicable Law has occurred or is expected to occur as a result of the transactions contemplated herein, (ii) no action, suit or other manner of litigation, or claim with respect to the assets thereof of any Benefit Plan is pending, threatened or imminent against or with respect to any of the Benefit Plans or any Group Companies, including any action, suit or other manner of litigation, or claim regarding conduct that allegedly interferes with the attainment of rights under any Benefit Plan, and (iii) to the knowledge of Sellers, no events have occurred and no circumstances exist which would give rise to or could give rise to any such actions, suits or other manner of litigation, or claims with respect to any Benefit Plan.

(e) Except as required by Applicable Law or as disclosed on Schedule 3.13(e) , none of the Group Companies maintains, contributes to, or has any liability (fixed, contingent or otherwise) for medical, health, life, or other welfare benefits for terminated employees or for present employees after termination of their employment.

(f) Schedule 3.13(f) sets forth a list as of the date hereof of all (i) employment agreements with current officers of any Group Company, (ii) agreements with consultants who are individuals obligating any Group Company to make annual cash payments in an amount of fifty thousand dollars ($50,000) or more, (iii) severance agreements, programs and policies of

 

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any Group Company with or relating to its employees, except such programs and policies required to be maintained by Applicable Law and (iv) plans, programs, agreements and other arrangements of any Group Company with or relating to its employees that contain change in control provisions. The Company has delivered to Buyer true and complete copies of all such agreements, plans, programs and other arrangements.

(g) Except as set forth on Schedule 3.13(g) , neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (i) result in any payment becoming due, or increase the amount of any compensation or benefits due, to any current or former employee of any Group Company or with respect to any Benefit Plan; (ii) increase any benefits otherwise payable under any Benefit Plan; or (iii) result in the acceleration of the time of payment or vesting of any such compensation or benefits.

3.14. Compliance with Law .

(a) The operation of the business of the Group Companies has been conducted in material compliance with all Applicable Laws and all Court Orders applicable to the Group Companies and required in the operations of its business. No Group Company has received any written notice to the effect that it is not in material compliance with any such regulations or Court Orders, and the Group Companies do not know of any existing circumstances that are reasonably likely to result in a material violation of any of the foregoing.

(b) No criminal activities have been carried out in favor or in the interest of the Group Companies which may, pursuant to the Italian Legislative Decree June 8, 2001 No. 231, as implemented and amended from time to time, or any other Applicable Laws, give rise to any liability of the Group Companies.

3.15. Permits . Schedule 3.15 sets forth a complete list of all Permits used in the operation of the Group Companies’ business or otherwise held by a Group Company, all of which are in full force and effect as of the date hereof. The Group Companies have all Permits required in the operation of their business and to own, lease and operate their properties and assets, and such Permits are in full force and effect and are owned by the Group Companies free and clear of all Encumbrances except Permitted Encumbrances, except such Permits the failure of which to obtain would not reasonably be expected to have a Material Adverse Effect on the Group Companies. No Group Company is in material Default and no event has occurred that with or without the passage of time or the giving of notice or both would give rise to a right of termination or acceleration, nor has any Group Company received any written notice of any claim of Default, with respect to any such Permit. Such Permits will not be adversely affected by the completion of the transactions contemplated by this Agreement. No suspension or cancellation of any such Permits is pending or, to the Knowledge of the Company, threatened.

3.16. Consents and Approvals . Except for the approval of this Agreement and the transactions contemplated hereby in accordance with the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “ HSR Act ”), no consent, notice, approval or authorization of, or filing or registration with, any Governmental Authority, or any other Person is required to be made, obtained or given by the Group Companies in connection with the execution, delivery and performance by the Group Companies of this Agreement and the

 

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consummation of the transactions contemplated hereby. The information provided by the Group Companies for inclusion in any notice or filing for purposes of approval of this Agreement and the transactions contemplated hereby in accordance with the HSR Act is true, complete and accurate.

3.17. Litigation . There is no action, suit, proceeding, claim, arbitration or investigation (“ Proceeding ”) pending (or, to the Knowledge of the Company, threatened) against any Group Company, or relating to its activities, properties or assets or, to the Knowledge of the Company, against any officer, director or employee of any Group Company in connection with such officer’s, director’s or employee’s relationship with, or actions taken on behalf of, any Group Company. To the Knowledge of the Company, there is no factual or legal basis for any such Proceeding that would be reasonably likely to result, individually or in the aggregate, in any Material Adverse Effect on the Group Companies. The Group Companies are not party to or subject to the provisions of any Court Order, writ, injunction, judgment or decree of any court or government agency or instrumentality, and there is no material Proceeding by any Group Company currently pending or which any Group Company intends to initiate.

3.18. Labor Matters .

(a) No Group Company is a party to or otherwise bound by any collective bargaining agreement or other labor union contract applicable to employees of any Group Company (other than the applicable Italian collective bargaining agreement) and, to the Knowledge of the Company, there are not any activities or proceedings of any labor union to organize any such employees. Additionally, (i) there is no unfair labor practice charge or complaint pending before any applicable Governmental Authority relating to any Group Company or any employee or other service provider thereof; (ii) there is no labor strike, material slowdown or material work stoppage or lockout pending or, to the Knowledge of the Company, threatened against or affecting any Group Company, and none of the Group Companies has within the last three years experienced any strike, material slowdown or material work stoppage, lockout or other collective labor action by or with respect to its employees; (iii) there is no representation claim or petition pending before any applicable Governmental Authority; and (iv) there are no charges with respect to or relating to any Group Company pending before any applicable Governmental Authority responsible for the prevention of unlawful employment practices.

(b) The Group Companies are and for the last five years have been in compliance in all material respects with all Applicable Laws and applicable collective bargaining agreements relating to employment of labor, including all Applicable Laws relating to wages, hours, overtime, collective bargaining, employment discrimination, civil rights, safety and health, workers’ compensation, pay equity, classification of employees and independent contractors, plant closings, relocations, mass layoffs and employment losses, hiring, promotion and termination of employees, and the collection and payment of withholding and/or social security Taxes. The Group Companies have fulfilled all of their obligations connected to or arising from any integrative welfare fund or integrative medical assistance or insurance fund provided for by the applicable collective bargaining agreements. Each Group Company has met in all material respects all requirements required by Applicable Law relating to the employment of foreign citizens, and no Group Company currently employs, or has ever employed, any Person who was not permitted to work in the jurisdiction in which such Person was employed.

 

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(c) No Group Company has within the last five years effectuated a plant closing or mass layoff or taken any other action that would trigger notice or liability under any Applicable Laws pertaining to plant closings, relocations, mass layoffs and employment losses.

(d) Neither the Company nor, to the Knowledge of the Company, any of the Group Companies’ employees is bound by any contract (including licenses, covenants or commitments of any nature) or subject to any judgment, decree or order of any Governmental Authority that would materially interfere with the use of such Person’s best efforts to promote the interests of the Group Companies or that would materially conflict with the Group Companies’ business as currently conducted.

(e) Schedule 3.18(e) lists all of the directors of the Group Companies, and their compensation from the commencement of the current fiscal year and the remainder of such fiscal year.

(f) The Group Companies have always complied and currently comply with all Applicable Laws and collective agreements in relation to work supply agreements (the so-called “contratti di somministrazione lavoro”); none of such work supply agreements have been structured, implemented or performed in a way so as to entitle any relevant counterparty to be recognized as indefinite-term employees or other type of employees of any of the Group Companies.

(g) The Group Companies are not liable, pursuant to Applicable Law governing joint liabilities of principals and contractors, for (x) the payment of any salaries due to employees of any of their contractors or (y) the payment of the social contributions accrued on the salaries referred to in clause (x) above. None of the employees of any contractors providing services to any of the Group Companies are, or could reasonably be considered to be, an employee of any of the Group Companies under Applicable Law.

3.19. Intellectual Property .

(a) Schedule 3.19(a) sets forth a complete and accurate list of all (1) patents and patent applications owned, used or held for use by the Group Companies and (2) trademark and service mark applications and registrations, registered copyrights and domain name registrations owned by the Group Companies, in each case (1) and (2), specifying as to each such item, as applicable (i) the owner of the item, (ii) the jurisdictions in which the item is issued or registered or in which any application for issuance or registration has been filed, (iii) the respective issuance, registration, or application number of the item, (iv) the date of application and issuance or registration of the item.

(b) Schedule 3.19(b) sets forth a complete and accurate list of all material licenses, sublicenses, consents and other agreements (whether written or otherwise) (i) pertaining to any Intellectual Property used or held for use by, or contemplated for use by, the Group Companies, including in relation to any Development Compound or a Development Product, and

 

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(ii) by which any Group Company licenses or otherwise authorizes a third party to use any Intellectual Property of a Group Company. No Group Company has a payment obligation to a third party relating to Intellectual Property used or held for use by any Group Company other than pursuant to the agreements listed in Schedule 3.19(b) .

(c) The Group Companies own all right, title and interest in and to, or are validly licensed or otherwise have a valid and enforceable right to use, and have the right to bring actions for the infringement or other violation of, all Intellectual Property owned, used or held for use in or necessary for the operation of the business of the Group Companies as it is currently conducted and/or, with respect to the Development Compound or Development Product as contemplated to be conducted.

(d) The business of the Group Companies as it is currently conducted or contemplated to be conducted, including any proposed written plans to make, have made, import, offer for sale, sell and otherwise develop and commercialize the Development Compound or a Development Product, does not infringe, dilute, misappropriate or otherwise violate the Intellectual Property rights of any third party, or constitute unfair competition or trade practices under the laws of any jurisdiction. Within the six (6) years prior to this Agreement, no third party has had any pending or threatened claims that any Group Company has infringed, diluted, misappropriated or otherwise violated any Intellectual Property of a third party.

(e) To the Knowledge of the Company, the Group Companies have sufficient right, title and interest in the Intellectual Property to exclude all other Persons from making, having made, importing, offering for sale, selling and otherwise developing or commercializing the Development Compound or a Development Product worldwide (excluding China and the territory covered by the Collaboration and License Agreement, in accordance with the terms of such agreement). Within the six (6) years prior to this Agreement, no Group Company has had any claim pending that a third party has infringed, diluted, misappropriated or otherwise violated any Intellectual Property of any Group Company.

(f) All of the Intellectual Property listed in Schedule 3.19(a) , and except as set forth in Schedule 3.19(f) , all granted patent claims that cover the Development Compound or a Development Product, or its method of pharmaceutical use or manufacture, in a patent listed in or licensed under an Agreement listed in Schedule 3.19(b) , are (i) to the Knowledge of the Company, valid and (ii) in full force and not the subject of any cancellation or reexamination proceeding or any other proceeding challenging their validity and (iii) either (a) are held of record in the name of a Group Company free and clear of all Encumbrances or licenses or other grants of rights to use (other than licenses set forth on Schedule 3.19(b) ), or (b) are held of record in the name of a licensor that has granted rights to the Group Companies under a license agreement listed in Schedule 3.19(b) . With respect to patents and patent applications listed on Schedule 3.19(a), no opposition, extension of time to oppose, rejection, priority claim or other refusal to register (other than preliminary office actions) has been received.

(g) The Group Companies have taken commercially reasonable confidentiality and security measures to safeguard and maintain their property rights in all confidential data and information owned by a Group Company.

 

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(h) All officers, employees, consultants or contractors of each Group Company with access to proprietary data and information owned by any Group Company have executed and delivered to such Group Company an agreement regarding the protection of proprietary data and information, and all employees, consultants and contractors of such Group Company who have created or developed, or contributed to the creation or development of, any Intellectual Property owned or purported to be owned by any Group Company, or whose job responsibilities include the creation or development of Intellectual Property, have signed agreements containing assignment of Intellectual Property rights to such Group Company. No current or prior officer, employee, consultant or contractor of the Group Companies has claimed in writing, and to the Knowledge of the Company, has any grounds to assert a claim to, or any ownership interest in, any Intellectual Property as a result of having been involved in the development of such property while employed or engaged by or consulting to the Group Companies.

(i) To the Knowledge of the Company, the Group Companies have made available to Buyer all material information in their possession or known to them with respect to the drug development pipeline of Advenchen Laboratories, LLC and its Affiliates.

3.20. Transactions with Certain Persons . No officer, director or securityholder of any Group Company or, to the Knowledge of the Company, any Affiliate or family member of any such Person has or has had, either directly or indirectly, a material interest in: (a) any person or entity which purchases from or sells, licenses or furnishes to any Group Company any material goods, property, technology, intellectual or other property rights or (b) any contract or agreement to which any Group Company is a party or by which it is bound or to which any of its properties or assets is subject.

3.21. Insurance . Schedule 3.21 sets forth a complete and correct list of all insurance policies of the Group Companies of any kind currently in force. True, correct and complete copies of such insurance policies have been made available to Buyer. All such insurance policies are in full force and effect. The Group Companies do not have any self-insurance or co-insurance programs. The Group Companies are not in Default under any provision of any such insurance policy, and no event has occurred that with or without the passage of time or the giving of notice or both would give rise to a right of termination or acceleration and the Group Companies have not received written notice of cancellation of any such insurance.

3.22. Certain Business Practices . None of the directors, officers, agents or employees of the Group Companies or any of their Affiliates has, in each case in connection with the Group Companies’ business, (a) used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses, including expenses related to political activity, or (b) made any unlawful payment to non-U.S. or domestic government officials or employees or to non-U.S. or domestic political parties or campaigns, made any bribes or kickback payments or violated any provision of the Foreign Corrupt Practices Act of 1977, as amended, or other similar non-U.S. laws.

3.23. No Broker . None of the Group Companies nor any of their partners, Representatives or Affiliates has entered into any contract, agreement, arrangement or understanding with any broker, finder or similar agent or any Person which will result in an obligation of Buyer, or any Group Company to pay any finder’s fee, brokerage fees or commission or similar payment in connection with the transactions contemplated hereby.

 

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3.24. Books and Records . The Group Companies have made and kept (and given Buyer access to) true, correct and complete books and records and accounts, which accurately and fairly reflect the activities of the Group Companies. The minute books of the Group Companies previously made available to Buyer accurately and adequately reflect in all material respects all action previously taken by the stockholders, board of directors, committees of the board of directors and board of statutory auditors of the Group Companies. The copies of the stock book records of the Group Companies previously made available to Buyer are true, correct and complete, and accurately reflect all transactions effected in the stock of the Group Companies through and including the date hereof.

3.25. Bank Accounts . Schedule 3.25 contains a true, correct and complete list of all bank accounts maintained by the Group Companies, including each account number and the name and address of each bank and the name of each person who has signature power with respect to each such account or power of attorney to act on behalf of such Group Company.

3.26. Drug Regulatory Agency and Related Matters . (a) The Group Companies are in compliance in all material respects with all written communications, including, but not limited to, all regulatory or warning letters, notices of adverse findings and similar letters or notices, between any Group Company and a Drug Regulatory Agency. The Group Companies are not subject to, and have not received written notice of, any criminal, injunctive, seizure or civil penalty actions begun or threatened by any Drug Regulatory Agency against any Group Company and all related consent decrees (including plea agreements) issued with respect to any Group Company.

(b) The Group Companies have no Knowledge (and have not been notified by a Company Partner (as defined below)) of any current regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any of the Group Companies or any Person that manufactures, develops or engages in preclinical or clinical study of the Development Compound pursuant to a development, contract research, commercialization, manufacturing, supply or other collaboration arrangement with the Group Companies (each, a “ Company Partner ”) by any Drug Regulatory Agency or any other duly authorized Governmental Authority which regulates the clinical testing or sale of drugs in any jurisdiction. To the Knowledge of the Company, none of the Group Companies or any Company Partner, has knowingly committed or permitted to exist any material violation of the rules and regulations of any Drug Regulatory Agency or any other duly authorized Governmental Authority that regulates the sale of drugs which has not been cured by the Group Companies or, to the Knowledge of the Company, any Company Partner, or waived by any Drug Regulatory Agency or any other Governmental Authority.

(c) All preclinical studies that have been conducted by or on behalf of the Group Companies or any licensor to the Group Companies, and clinical trials that have been or are being conducted by the Group Companies, have been or are being conducted in compliance with the applicable requirements of Good Laboratory Practices or Good Clinical Practices, each as applicable, except for such noncompliance which is not, individually or in the aggregate, reasonably likely to have a Material Adverse Effect on the Group Companies.

 

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(d) The manufacture of the Development Compound by the Group Companies is, or, in the case of the Development Compound manufactured by a Company Partner, to the Knowledge of the Company is, being conducted in compliance with the EMA’s applicable current Good Manufacturing Practices regulations for drug products, as applicable, except for such noncompliance which is not, individually or in the aggregate, reasonably likely to have a Material Adverse Effect on the Group Companies. In addition, the Group Companies are in compliance with all applicable registration and listing requirements set forth in Directive 2003/94/EC and all similar Applicable Laws, except for such noncompliance which is not, individually or in the aggregate, reasonably likely to have a Material Adverse Effect on the Group Companies. The Group Companies have not received notice from any Company Partner of, and to the Knowledge of the Company, there does not currently exist, any material interruption of supply or manufacturing capacity, shortage of raw materials, components or other manufacturing problems that would have a material effect on the subsequent development or commercialization (as such development or commercialization is contemplated as of the date of this Agreement) of the Development Compound.

(e) None of the Group Companies or, to the Knowledge of the Company, any of their respective employees, agents or subcontractors, has been convicted of any crime or engaged in any conduct which could result in debarment or disqualification by any Drug Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened in writing that reasonably might be expected to result in criminal liability or debarment or disqualification by any Drug Regulatory Agency.

(f) The Group Companies have made available to Buyer all material information known to them with respect to the safety and efficacy of the Development Compound. The Group Companies have no Knowledge of any Serious Adverse Event associated with clinical trials of the products containing the Development Compound of the Group Companies whether conducted by or on behalf of any Group Company that have not been reported to applicable Drug Regulatory Agencies and other applicable Governmental Authorities in accordance with Applicable Law.

(g) The Group Companies have made available to Buyer a copy of all Drug Regulatory Agency (i) inspection reports, (ii) notices of adverse findings, warning, untitled letters, minutes of meetings, or (iii) other correspondence from any Drug Regulatory Agency concerning the Development Compound in their possession in which any Drug Regulatory Agency asserted that the operations of any Group Company may not be in compliance with Applicable Laws or that the Development Compound may not be safe, effective, or approvable.

ARTICLE IV.

REPRESENTATIONS AND WARRANTIES OF THE SELLERS

As a material inducement to Buyer to enter into this Agreement, except as disclosed in the Disclosure Schedule, each Seller, severally and not jointly, hereby makes the following representations and warranties to Buyer as of the date hereof and as of the Closing Date.

 

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4.1. Authorization . If such Seller is not an individual: (i) such Seller is a company duly organized, validly existing and in good standing under the laws of its place of organization; (ii) such Seller has all requisite power and authority, and has taken all action necessary, to execute, deliver and perform this Agreement, to consummate the transactions contemplated hereby and to perform its obligations hereunder; (iii) the execution and delivery of this Agreement and the consummation by such Seller of the transactions contemplated hereby have been duly approved by all necessary action on the part of such Seller, and (iv) no other proceeding on the part of such Seller is necessary to authorize this Agreement and the transactions contemplated hereby. This Agreement has been duly executed and delivered by such Seller and is the legal, valid and binding obligation of such Seller, enforceable against such Seller in accordance with its terms except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws affecting creditors’ rights generally and except insofar as the availability of equitable remedies may be limited by Applicable Law.

4.2. Title to the Shares . Such Seller owns of record and beneficially all of the Shares set forth opposite such Seller’s name on Exhibit 2.3(c) , free and clear of all Encumbrances.

4.3. Compliance with Other Instruments . The execution, delivery and performance of and compliance with this Agreement and the consummation of the transactions contemplated hereby will not (a) if such Seller is not an individual, result in a violation of, or be in conflict with or constitute, with or without the passage of time or the giving of notice or both, either a violation of, or conflict with the organizational documents of such Seller, as applicable, or, assuming the consents and approvals referred to in Section 3.16 are duly obtained, a violation of, or conflict with any Applicable Laws or Court Orders applicable to such Seller or (b) violate, conflict with, result in any breach of, constitute a Default under, or give to others any rights of termination, renegotiation or acceleration, or result in the creation of any Encumbrance (other than a Permitted Encumbrance) upon any of the properties or assets of such Seller, any contract or permit to which any such Seller is a party or by which any of such properties or assets are bound or affected, except (in the case of this clause (b) only) for any such violation, conflict, breach or Default which would not prevent or materially delay consummation of the transaction contemplated hereby or otherwise prevent such Seller from complying with the terms and provisions of this Agreement.

4.4. Consents and Approvals . Except for the approval of this Agreement and the transactions contemplated hereby in accordance with the HSR Act, no consent, notice, approval or authorization of, or filing or registration with, any Governmental Authority, or any other Person is required to be made, obtained or given by such Seller in connection with the execution, delivery and performance by such Seller of this Agreement and the consummation of the transactions contemplated hereby. The information provided by such Seller for inclusion in any notice or filing for purposes of approval of this Agreement and the transactions contemplated hereby in accordance with the HSR Act is true, complete and accurate.

 

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4.5. Litigation . There is no Proceeding pending (or, to such Seller’s actual knowledge, threatened) against such Seller that would prevent or materially delay the consummation of the transaction contemplated hereby or otherwise prevent such Seller from complying with the terms and provisions of this Agreement. Such Seller is not party to or subject to the provisions of any Court Order, writ, injunction, judgment or decree of any court or government agency or instrumentality that would prevent or materially delay the consummation of the transactions contemplated hereby.

4.6. [Intentionally left blank] .

4.7. No Broker . Neither such Seller nor any of its respective partners, Representatives or Affiliates has entered into any contract, agreement, arrangement or understanding with any broker, finder or similar agent or any Person which will result in an obligation of Buyer, any Group Company, or any of their respective Affiliates to pay any finder’s fee, brokerage fees or commission or similar payment in connection with the transactions contemplated hereby. No Seller nor any Affiliate of any Seller (other than the Group Companies) is party to, or has any rights under any confidentiality agreement or similar agreement pursuant to which information or due diligence items that relate to the Group Companies or the business of the Group Companies were provided to any other Person.

4.8. Accredited Investor . Except as set forth on Schedule 4.8 , each Seller is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

4.9. Acquisition for Investment . The acquisition by such Seller of any shares of Buyer Common Stock pursuant to the terms of this Agreement shall be for its own account and not with a view to or for sale in connection with the distribution thereof. Except in accordance with Applicable Law, such Seller does not have a present intention to sell any of the shares of Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement. Such Seller acknowledges that it (i) has such knowledge and experience in financial and business matters and is capable of evaluating the merits and risks of its investment in Buyer Common Stock, (ii) is able to bear the economic risks associated with an investment in Buyer Common Stock, and (iii) can bear a total loss of such investment therein.

4.10. Disclosure . Such Seller acknowledges that Buyer has made available to Seller the opportunity to ask questions of, and to receive answers from, persons acting on behalf of Buyer concerning Buyer Common Stock and to obtain any additional information desired by such Seller with respect to Buyer and its subsidiaries.

4.11. Restricted Securities .

(a) Such Seller understands that any shares of Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement will not be registered as of the Closing under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of such Seller’s representations as expressed herein. Such Seller understands that any shares of Buyer Common Stock that such Seller acquires pursuant to

 

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the terms of this Agreement will be “restricted securities” under applicable United States federal and state securities laws and that, pursuant to these laws, such Seller must hold any shares of Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement indefinitely unless sold pursuant to a registration statement that has been declared effective under the Securities Act or in compliance with Rule 144 promulgated thereunder. As a result, such Seller acknowledges that the certificates evidencing Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement will bear the following legend or a similar legend reflecting the restrictions on the transfer of such securities contained in this Agreement:

“THE SECURITIES EVIDENCED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR ANY STATE SECURITIES LAWS AND MAY NOT BE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION UNDER THE ACT OF SUCH LAWS OR IN A TRANSACTION WHICH, IN THE OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER, QUALIFIED AS AN EXEMPT TRANSACTION UNDER THE ACT AND SUCH LAWS AND THE RULES AND REGULATIONS PROMULGATED THEREUNDER.”

(b) Such Seller understands that no United States federal or state agency or any Governmental Authority has passed upon or made any recommendation or endorsement of any shares of Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement.

4.12. No General Solicitation . Such Seller acknowledges that any shares of Buyer Common Stock that such Seller acquires pursuant to the terms of this Agreement were not acquired by such Seller as a result of or subsequent to any general or public solicitation, including (i) any advertisement, article, notice or other communication published in any newspaper, magazine, or similar media, or broadcast over television or radio, or (ii) any seminar or meeting to which such Seller was invited by any of the foregoing means of communication.

ARTICLE V.

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer hereby makes the following representations and warranties to the Company and the Sellers as of the date hereof and as of the Closing Date.

5.1. Organization . Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware with full power and authority to conduct its business as it is presently being conducted, and to own, lease or operate, as applicable, its assets and properties, and to perform all its obligations under its contracts. Buyer is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction where the character of its properties owned, leased or operated or the nature of its activities make such qualification necessary, except where the failure to be so qualified or in good standing would not have a Material Adverse Effect on Buyer. Buyer is not in violation of its certificate of incorporation or bylaws.

 

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5.2. Authorization . Buyer has all requisite power and authority, and has taken all action necessary, to execute and deliver this Agreement to consummate the transactions contemplated hereby and to perform its obligations hereunder. The execution and delivery of this Agreement and the consummation by Buyer of the transactions contemplated hereby have been duly approved by the board of directors of Buyer. No other proceeding on the part of Buyer is necessary to authorize this Agreement and the transactions contemplated hereby. This Agreement has been duly executed and delivered by Buyer and is a legal, valid and binding obligation of Buyer, enforceable against Buyer in accordance with its respective terms except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws affecting creditors’ rights generally and except insofar as the availability of equitable remedies may be limited by Applicable Law.

5.3. Compliance with Other Instruments . The execution, delivery and performance of and compliance with this Agreement and the consummation of the transactions contemplated hereby will not (a) result in a violation of, or be in conflict with or constitute, with or without the passage of time or the giving of notice or both, either a violation of, or conflict with the certificate of incorporation or bylaws of Buyer, or, assuming that the consents and approvals referred to in Section 5.5 are duly obtained, a violation of, or conflict with any Applicable Laws or Court Orders applicable to Buyer, or (b) violate, conflict with, result in any breach of, constitute a Default under, or give to others any rights of termination or acceleration, or result in the creation of any Encumbrance (other than a Permitted Encumbrance) upon any of the properties or assets of Buyer, any contract or permit to which any Buyer is a party or by which any of such properties or assets are bound or affected, except (in the case of this clause (b) only) for any such violation, conflict, breach or Default which would not have a Material Adverse Effect on Buyer.

5.4. Compliance with Law . The business of Buyer has been conducted in material compliance with all Applicable Laws and all Court Orders applicable to Buyer and required in the operations of its business. Buyer has not received any notice to the effect that, or otherwise been advised that, it is not in material compliance with any such Applicable Laws or Court Orders, and Buyer does not know of any existing circumstances that are likely to result in violations of any of the foregoing.

5.5. Consents and Approvals . Except for (i) the approval of this Agreement and the transactions contemplated hereby in accordance with the HSR Act and (ii) the filing of a registration statement in connection with the resale of the Share Consideration pursuant to the Registration Rights Agreement with the SEC, no consent, approval or authorization of, declaration to, or filing or registration with, any Governmental Authority, or any other Person, is required to be made or obtained by Buyer in connection with the execution, delivery and performance by Buyer of this Agreement and the consummation of the transactions contemplated hereby.

5.6. Litigation . There are no Proceedings pending, or to the knowledge of Buyer, threatened against or affecting Buyer, that have or might be reasonably expected to have a Material Adverse Effect on Buyer.

 

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5.7. No Broker . Neither Buyer nor any of its respective partners, Representatives or Affiliates has entered into, nor will enter into any contract, agreement, arrangement or understanding with any broker, finder or similar agent or any Person which will result in the obligation of the Sellers to pay any finder’s fee, brokerage fees or commission or similar payment in connection with the transactions contemplated hereby.

5.8. SEC Filings .

(a) Buyer’s SEC Reports complied as to form in all material respects with the requirements of the Exchange Act in effect on the date of filing. Buyer’s SEC Reports, when taken as a whole, do not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.

(b) Each of Buyer’s financial statements (including the related notes) included in Buyer’s SEC Reports present fairly in all material respects the consolidated financial position and consolidated results of operations and cash flows of Buyer and its Subsidiaries as of the respective dates or for the respective periods set forth therein, all in conformity with U.S. GAAP consistently applied during the period involved, except as otherwise noted therein, and subject, in the case of any unaudited interim financial statements included therein, to normal year-end adjustments and to the absence of complete footnotes.

(c) Since September 30, 2013, no event, change, circumstance, effect, development or state of facts, violation, inaccuracy or other matter has occurred, which individually or in the aggregate, has had, or would reasonably be expected to have, a Material Adverse Effect on Buyer.

5.9. Limited Representations . Except for the representations and warranties contained in Article III and Article IV (including the related portions of the Disclosure Schedule), none of the Sellers, the Company or any other Person has made or makes any other express or implied representation or warranty, either written or oral, on behalf of Sellers or the Company. In connection with the investigation by Buyer of the Company, Buyer has received from the Sellers or the Company certain projections, forward-looking statements and other forecasts and certain business plan information. Buyer acknowledges that there are uncertainties inherent in attempting to make such estimates, projections and other forecasts and plans, that Buyer is familiar with such uncertainties and that Buyer is taking full responsibility for making their own evaluation of the adequacy and accuracy of all estimates, projections and other forecasts and plans so furnished to them. Accordingly, Buyer acknowledges that the Sellers and the Company make no representation or warranty with respect to such estimates, projections, forecasts or plans (including the reasonableness of the assumptions underlying such estimates, projections, forecasts or plans) and the Buyer has not relied on any such estimates, projections, forecasts or plans.

5.10. Buyer Common Stock . The shares of Buyer Common Stock included in the Share Consideration, when issued to the Sellers in accordance with the terms and conditions of this Agreement, will be duly authorized and validly issued, fully paid and nonassessable. Assuming the accuracy of the representations of each Seller in Sections 4.8, 4.9, 4.10, 4.11 and 4.12 , the Share Consideration will be issued in compliance with all applicable federal and state securities laws.

 

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ARTICLE VI.

ADDITIONAL AGREEMENTS

6.1. Conduct of Business by the Company . During the period from the date hereof and continuing until the Closing, the Company shall (i) carry on its business in the Ordinary Course and in material compliance with all Applicable Law, (ii) use commercially reasonable efforts to preserve intact its present business organization, including the services of its key employees and the goodwill of its lenders, suppliers, regulators and other Persons with whom it has business relationships.

6.2. Confidentiality . Each Seller covenants and agrees that such Seller shall keep secret and retain in strictest confidence, and shall not furnish, make available or disclose to any third party or use for such Seller’s own benefit or the benefit of any third party, any Confidential Information, unless such information (i) was or becomes available to the public from a source other than any Seller or any Affiliate of a Seller, (ii) is requested to be disclosed by a Governmental Authority or required by Applicable Law (in which case the disclosing Seller shall, to the extent reasonably practicable and legally permissible, provide Buyer with advance notice of such required or requested disclosure, shall use commercially reasonable efforts (at Buyer’s sole cost and expense) to resist such disclosure, and, at the request of Buyer, shall cooperate with Buyer to, at Buyer’s sole cost and expense, limit or prevent such disclosure), or (iii) becomes available to such Seller after the date hereof on a non-confidential basis from a source other than the Group Companies; provided , that such other source is not known by Seller to be bound by a confidentiality agreement with or other contractual, legal or fiduciary obligation of confidentiality on nonuse to Buyer or any of its Affiliates or any other person with respect to such information. As used herein, “ Confidential Information ” shall mean any information relating to the business or affairs of the Group Companies, including, but not limited to, their development plans, costs, finances, marketing plans, equipment configurations, data, databases, access or securities codes or procedures, business opportunities, names of and contact information for business relations, research and development, inventions, algorithms, know-how and other proprietary information used by any of the Group Companies in connection with their business.

6.3. Public Disclosure .

(a) Without limiting any other provision of this Agreement, Buyer and Sellers’ Representative shall be consulted before the issuance of, and provided with the opportunity to review, comment upon and concur with, and agree on, any press release or public statement with respect to this Agreement and the transactions contemplated hereby, and neither Buyer nor any Seller (or Group Company prior to the Closing) shall issue any such press release or make any such public statement prior to such consultation and agreement, except as may be required by Applicable Law.

 

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(b) The Parties have agreed to the text of the joint press release announcing the execution of this Agreement. Buyer will file a current report on Form-8-K with the SEC immediately after execution hereof containing a description of this Agreement, which description shall be as agreed by the Sellers’ Representative and Buyer.

6.4. [Intentionally left blank] .

6.5. Buyer Director . No later than the 2015 annual meeting of the stockholders of Buyer, Buyer shall use its reasonable best efforts to have designated, nominated and/or appointed one director to the board of directors of Buyer mutually agreed to by Buyer and Sellers entitled to receive 66 and 2/3 of the Subsequent Consideration, subject to Applicable Law and stock exchange rules (including Nasdaq FAQ Identification Number 292); provided , that Buyer shall have no further obligation under this Section 6.5 as of the first date that the Sellers (excluding any assignees or transferees thereof) do not hold, in the aggregate, the right to receive at least fifty percent (50%) of the potential remaining Subsequent Consideration.

6.6. Covenant Not to Compete .

(a) Each Seller acknowledges that the agreements and covenants contained in this Section 6.6 are essential to protect the value of the Shares being acquired by Buyer. Therefore, each Seller agrees that for the period commencing on the Closing Date and ending on the fifth (5 th ) anniversary of the Closing Date, such Seller shall not, and shall not permit its Affiliates to, anywhere in the world, participate or engage, directly or indirectly, for themselves or on behalf of or in conjunction with any Person, as an employee, agent, officer, consultant, director, shareholder, partner, joint venture or investor or otherwise, in any research, development, manufacture, sale, investment, or otherwise engage in any business involving, the items set forth on Exhibit 6.6(a) .

(b) The Sellers agree that a monetary remedy for a breach of the agreement set forth in Section 6.6(a) would be inadequate and impracticable and further agree that such a breach would cause Buyer irreparable harm. In the event of such a breach, the Sellers agree that, in addition to other equitable remedies, Buyer shall be entitled to such injunctive relief, including temporary restraining orders, preliminary injunctions and permanent injunctions as a court of competent jurisdiction shall determine, without the necessity of proving actual damages.

(c) If any provision of this Section 6.6 is invalid in part, it shall be curtailed, as to time, location or scope, to the minimum extent required for its validity under Applicable Laws and shall be binding and enforceable with respect to the Sellers and their Affiliates as so curtailed.

6.7. Resignation of Statutory Auditors . If requested by Buyer, the Sellers will request the resignation of the statutory auditors of the Group Companies.

 

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6.8. Indemnification of Directors and Officers .

(a) Buyer agrees that all rights to indemnification existing as of the date of this Agreement and permissible under Applicable Law for acts or omissions occurring prior to the Closing in favor of any current or former director, statutory auditor or officer of the Group Companies (each, a “ Covered Person ”) as provided in the Group Companies respective organizational documents, individual indemnity agreements or as provided pursuant to a resolution of the directors or managers of a Group Company, as applicable, in each case set forth on Exhibit 6.8(a) , shall survive the Closing and shall not be amended, repealed or otherwise modified and shall continue in full force and effect in accordance with their terms for a period of six (6) years from the Closing Date.

(b) At or prior to the Closing, Buyer shall purchase a six (6) year non-cancellable “tail” prepaid directors’ and officers’ liability insurance policy covering the Covered Persons, which provides at least the same coverage and amounts and containing terms and conditions which are no less favorable to the Covered Persons than the policies maintained as of the date hereof (the “ D&O Tail ”), effective as of the Closing.

(c) The provisions of this Section 6.8 are (i) intended to be for the benefit of, and shall be enforceable by, the Covered Persons, their heirs, legatees, representatives, successors and assigns, it being expressly agreed that the Covered Persons shall be third party beneficiaries of this Section 6.8 and (ii) in addition to, and not in substitution for, any other rights to indemnification or contribution that any such Covered Person may have by contract or otherwise.

(d) In the event any Group Company or any of their respective successors or assigns (i) consolidates or mergers into any other person and is not the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers or conveys all or substantially all of its properties and assets to any person, then, and in each such case, Buyer shall cause proper provisions to be made so that the successors and permitted assigns of the Group Companies or any of their respective successors or assigns, as the case may be, assume the obligations set forth in this Section 6.8 .

6.9. Tax Matters .

(a) The Parties shall cooperate fully, as and to the extent reasonably requested by any of them, in connection with the filing of Tax Returns pursuant to this Agreement and any audit, litigation or other proceeding with respect to Taxes. In this regard, Buyer shall retain all books and records with respect to Tax matters of the Company which are or may be pertinent to any Tax period beginning before the Closing Date until the expiration of the applicable statute of limitations and shall make them available to the Sellers’ Representative in connection with any audit of the Company which could give rise to an indemnification obligation of any of the Sellers. The Buyer agrees to use commercially reasonable efforts to use any available Tax credit that may reduce Pre-Closing Taxes consistent with Applicable Law.

(b) Transfer Taxes . All transfer, documentary, sales, use, stamp, registration and other such Taxes, and all conveyance fees, recording charges and other fees and charges (including any penalties and interest) incurred in connection with consummation of the transactions contemplated by this Agreement (including Italian Tax on Financial Transactions pursuant to article 1, par. 491 of law 228 of December 24, 2012), if any, shall be borne and paid by Buyer. Buyer shall prepare and timely file all Tax Returns required to be filed in respect of

 

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any such charges. For avoidance of doubt, the Parties hereby expressly agree and acknowledge that this provision shall not be applicable to any capital gain tax possibly due under any Applicable Law in connection with this Agreement, it being understood that such possible capital gain tax, if due, shall be solely and entirely borne by the Sellers.

6.10. Development and Commercialization of the Development Products .

(a) Buyer may direct, modify and terminate the clinical development or commercialization of any Development Product or the Development Compound or any products related thereto at any time, based upon its assessment, in its sole discretion, due to scientific, technical, regulatory or commercial reasons, including (a) safety or efficacy concerns, including adverse events of any Development Product or the Development Compound, (b) concerns relating to the present or future marketability or profitability of any Development Product or the Development Compound, (c) reasons related to Intellectual Property coverage of any Development Product or the Development Compound or (d) existing and anticipated competition that renders the clinical development or commercialization of any Development Product or the Development Compound no longer commercially practicable.

(b) Buyer shall not, and will not permit its Subsidiaries (including after the Closing, the Group Companies) to, modify amend or waive, or consent to modify, amend or waive, any provision of the Collaboration and License Agreement in a manner that would delay the payment of, adversely affect the likelihood of payment of, or impose additional restrictions on the payment of the EMA Subsequent Payment Amount, the MA Subsequent Payment Amount or the Sales Subsequent Payment Amount. Buyer shall not, and will not permit its Subsidiaries (including after the Closing, the Group Companies) to, create a lien, pledge or security interest on any payments to be made by Servier pursuant to the Collaboration and License Agreement to the Company, or to be paid to Sellers.

(c) Subject to Section 6.10(a) , following the Closing, Buyer shall use commercially reasonable efforts to achieve each of the Milestones and to develop and commercialize the Development Compound in the United States. Buyer agrees that it will not, and will not permit its Affiliates (including after the Closing, the Group Companies) to, take any action with the primary intent of preventing or materially delaying the achievement of any Milestone.

(d) Buyer shall cause the Company to comply with all of its obligations, and cause the Company to use commercially reasonable efforts to enforce its rights, under the Collaboration and License Agreement and the Group Companies’ agreements with Advenchen Laboratories, LLC.

6.11. Seller Release .

(a) From and after the Closing, none of Buyer, the Company or any of their respective Affiliates, predecessors, successors, parent corporations, Subsidiaries, stockholders, current or former directors, officers, employees, consultants, attorneys, agents, assigns and employee benefit plans (the “ Seller Released Parties ”) shall have any obligation or liability to any undersigned Seller, or his, her or its successors or assigns, in his, her or its capacity as a

 

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Seller and/or as a director, officer and employee of the Company or any of its Subsidiaries (as applicable), whether arising prior to, on or after the Closing (so long as the events giving rise to the liability or obligation occurred prior to the Closing) including with respect to the allocation of the Transaction Consideration among Sellers (such obligations and liabilities, with the exception of the Specified Obligations, the “ Seller Released Obligations ”), except for (i) rights and claims for indemnification to the extent a Seller Indemnified Party is entitled to be indemnified by Buyer under Article VII of this Agreement, (ii) the undersigned Seller’s right to full and complete payment for its Shares, (iii) if the undersigned Seller is an officer, director or employee of any Group Company, rights under any Benefit Plan (other than any such plan that provides for equity-based compensation), rights to earned but unpaid wages or compensation, unpaid vacation or sick pay or unreimbursed business expenses and (iv) the third party beneficiary rights, if any, described in Section 6.8(b) (items (i) through (iv), the “ Specified Obligations ”); provided , that the foregoing shall not preclude the undersigned Seller from seeking recovery under the D&O Tail to the extent such coverage is available.

(b) Effective from and after the Closing, the undersigned Seller, for himself, herself or itself and on behalf of his, her or its successors and assigns, irrevocably and unconditionally waives, releases and promises never to assert any claims or causes of action, promises or similar rights of any type (however described and however arising) that the undersigned Seller or any of his, her or its successors and assigns may currently have, or may have in the future, whether or not now known, against any Seller Released Party with respect to any matter related to the Seller Released Obligations (the “ Seller Released Claims ”).

(c) Prior to the Closing, except for any Specified Obligations, the Sellers shall cause all accounts, arrangements and agreements between any Seller or any Affiliate of Seller, on the one hand, and the Company or any Company Subsidiary, on the other hand, to be settled, discharged, terminated and satisfied, in all respects, with no continuing obligation or liability of the Seller Released Parties, including the Group Companies following the Closing.

(d) The undersigned Seller acknowledges that he, she or it may hereafter discover facts other than or different from those that he, she or it knows or believes to be true with respect to the subject matter of the Seller Released Claims, but he, she or it hereby expressly agrees that, on and as of the Closing, such Seller shall have waived and fully, finally and forever settled and released any known or unknown, suspected or unsuspected, asserted or unasserted, contingent or noncontingent claim with respect to the Seller Released Claims, whether or not concealed or hidden, without regard to the subsequent discovery or existence of such different or additional facts.

6.12. Buyer Release .

(a) From and after the Closing, none of the undersigned Sellers or any of their respective Affiliates, predecessors, successors, parent corporations, Subsidiaries, stockholders, current or former directors, officers, employees, consultants, attorneys, agents, assigns and employee benefit plans (the “ Buyer Released Parties ”) shall have any obligation or liability to Buyer, the Group Companies or any of their respective Affiliates, predecessors, successors, parent corporations, Subsidiaries, stockholders, current or former directors, officers, employees, consultants, attorneys, agents, assigns and employee benefit plans, in such Buyer Released

 

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Parties’ capacity as a director, officer, employee, stockholder, beneficial owner, consultant, attorney or agent of the Group Companies, whether arising prior to, on or after the Closing (so long as the events giving rise to the liability or obligation occurred prior to the Closing) (such obligations and liabilities, the “ Buyer Released Obligations ”), except for fraud, gross negligence or willful misconduct; provided , that this Section 6.12 shall not affect any obligations or liabilities of any Buyer Released Parties under any rights and claims for indemnification to the extent a Buyer Indemnified Party is entitled to be indemnified under Article VII of this Agreement or pursuant to any agreement between a Group Company and any Seller or its Affiliates that survives the Closing.

(b) Effective from and after the Closing, Buyer and the Group Companies, for itself and on behalf of its successors and assigns, irrevocably and unconditionally waives, releases and promises never to assert any claims or causes of action, promises or similar rights of any type (however described and however arising) that Buyer, the Group Companies or any of their successors and assigns may currently have, or may have in the future, whether or not now known, against any Buyer Released Party with respect to any matter related to the Buyer Released Obligations (the “ Buyer Released Claims ”).

(c) Buyer and the Group Companies acknowledges that they may hereafter discover facts other than or different from those that they know or believe to be true with respect to the subject matter of the Buyer Released Claims, but they hereby expressly agree that, on and as of the Closing, such Party shall have waived and fully, finally and forever settled and released any known or unknown, suspected or unsuspected, asserted or unasserted, contingent or noncontingent claim with respect to the Buyer Released Claims, whether or not concealed or hidden, without regard to the subsequent discovery or existence of such different or additional facts.

6.13. Further Assurances . From and after the Closing Date, at Buyer’s reasonable request and expense, each of the Sellers and the Sellers’ Representative shall execute and deliver such instruments of conveyance and transfer and take such other actions necessary in order to (a) perfect and record, if necessary, the sale, assignment, conveyance, transfer, and delivery to Buyer of the Shares, (b) convey, transfer to and vest in Buyer and to put Buyer in possession and operating control of all or any part of the Group Companies, and (c) give effect to the transactions contemplated hereby.

ARTICLE VII.

INDEMNIFICATION

7.1. Survival of Representations . The representations and warranties contained herein shall survive the Closing Date until twelve (12) months thereafter; provided , however , that (i) the representations and warranties set forth in Sections 3.1 (Organization), 3.2 (Subsidiaries), 3.3 (Authorization), 3.4 (Capitalization), 4.1 (Authorization), 4.2 (Title to the Shares), 4.8 (Accredited Investor), 4.9 (Acquisition for Investment), 4.10 (Disclosure), 4.11 (Restricted Securities), 4.12 (No General Solicitation), 5.1 (Organization) and 5.2 (Authorization) shall survive in perpetuity, (ii) Section 3.19 (Intellectual Property) shall survive the Closing Date until one (1) year following the first commercial sale of the Development Product and

 

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(iii)  Sections 3.11 (Taxes), 3.23 (No Broker), 4.7 (No Broker) and 5.7 (No Broker) shall survive the Closing Date until sixty days following the expiration of any applicable statute of limitations (including any extensions thereof). Any claims under this Agreement with respect to a breach of a representation and warranty must be asserted by written notice within the applicable survival period contemplated by this Section 7.1 , and if such notice is given, the survival period for such representation and warranty shall continue until the claim is fully resolved. The right to indemnification or other remedy based on the representations, warranties, covenants and agreements herein shall not be affected by any investigation conducted with respect to, or any knowledge (or capable of being acquired) at any time, whether before or after the execution and delivery of this Agreement, with respect to the accuracy or inaccuracy of or compliance with, any such representation, warranty, covenant or agreement.

7.2. Indemnification .

(a)(i) Subsequent to the Closing, subject to the provisions of this Article VII , including the limitations described below in Section 7.5 , each of Buyer and its respective Affiliates (including, after the Closing, the Group Companies) and each of its and their respective officers, directors, employees, stockholders and agents (the “ Buyer Indemnified Parties ”) shall be indemnified and reimbursed by the Sellers severally (in accordance with their respective Pro Rata Percentages) from and against any and all damage, claim, loss, cost, liability or expense, including interest, penalties, reasonable attorneys’ fees and expenses of investigation, response action, removal action or remedial action (collectively, “ Damages ”) incurred by such Buyer Indemnified Party that arise out of (v) any breach of any representation or warranty made by the Company in Article III ; (w) any failure to perform any covenant or obligation made by the Company in this Agreement; (x) any Pre-Closing Taxes; or (y) any Buyer Indemnified Party’s enforcement of its rights under this Section 7.2(a)(i) .

(ii) Subsequent to the Closing, subject to the provisions of this Article VII , including the limitations described below in Section 7.5 , the Buyer Indemnified Parties shall be indemnified and reimbursed by the Sellers, severally and not jointly, from and against any and all Damages incurred by such Buyer Indemnified Party that arise out of (x) any breach of any representation or warranty made by such Seller in Article IV ; (y) any failure to perform any covenant or obligation made by such Seller in or pursuant to this Agreement; or (z) any Buyer Indemnified Party’s enforcement of its rights under this Section 7.2(a)(ii) .

(iii) Subsequent to the Closing, subject to the provisions of this Article VII , including the limitations described below in Section 7.5 , Buyer shall indemnify and reimburse each Seller and its respective Affiliates and each of its and their respective officers, directors, employees, stockholders and agents (the “ Seller Indemnified Parties ” and collectively with the Buyer Indemnified Parties, the “ Covered Parties ”) from and against any and all Damages asserted against, suffered, sustained, accrued or incurred by such Seller Indemnified Party arising out of (x) any breach of any representation or warranty made by Buyer in Article V ; (y) any failure to perform any covenant or obligation made by Buyer in or pursuant to this Agreement; or (z) any Seller Indemnified Party’s enforcement of its rights under this Section 7.2(a)(iii) .

 

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(b) The term “Damages” as used in this Article VII is not limited to matters asserted by third parties against the Covered Parties, but includes Damages actually incurred or sustained by such persons in the absence of third-party claims, and payments by a Covered Party shall not be a condition precedent to recovery, and shall be net of any insurance proceeds or other recoveries actually received that relate to the event giving rise to such Damages. Notwithstanding the foregoing, the term “Damages” shall not include any punitive, incidental, consequential, special or indirect damages, including loss of future revenue or income, or loss of business reputation or opportunity, except, in each case, for any such damages awarded to a third party in third-party claims.

7.3. Notice of Claims . Any Covered Party seeking indemnification hereunder shall, within the relevant limitation period provided for in Section 7.1 above, give to the Party which is obligated pursuant to this Article VII to provide indemnification as set forth herein (the “ Indemnifying Party ”) a notice (a “ Claim Notice ”) describing in reasonable detail the facts giving rise to any claims for indemnification hereunder and shall include in such Claim Notice (if then known) the amount or the method of computation of the amount of such claim, and a reference to the provision of this Agreement or any agreement, certificate or instrument executed pursuant hereto or in connection herewith upon which such claim is based; provided that a Claim Notice in respect of any action at law or suit in equity by or against a third Person as to which indemnification shall be sought shall be given promptly after the action or suit is commenced; and provided further that failure to give such notice shall not affect such Covered Party’s right to indemnification hereunder except to the extent the Indemnifying Party shall have been materially prejudiced by such failure.

7.4. Third Person Claims . If a claim by a third Person is made against a Covered Party, and if such party intends to seek indemnity with respect thereto under this Article VII , such Covered Party shall promptly notify the Indemnifying Party in writing of such claims, setting forth such claims in reasonable detail. The Indemnifying Party shall have twenty (20) days following receipt of such notice to deliver to the Covered Party a written acknowledgement that such claim is an indemnifiable claim under this Article VII , that it shall undertake, conduct and control (in accordance with the terms hereof), through counsel of their own choosing and at their own expense, the settlement or defense thereof, and the Covered Party shall cooperate with them in connection therewith; provided , that , the Covered Party may participate in such settlement or defense through counsel chosen by such Covered Party and paid at its own expense, provided further that, if in the reasonable opinion of counsel for Indemnifying Party, there is a reasonable likelihood of a conflict of interest between the Indemnifying Party and the Covered Party, the Indemnifying Party shall be responsible for reasonable fees and expenses of one counsel to such Covered Party in connection with such defense. The Covered Party shall not pay or settle any such claim without the consent of the Sellers’ Representative with respect to claims where the Sellers are the Indemnifying Party and Buyer where Buyer is the Indemnifying Party. If the Indemnifying Party does not deliver to the Covered Party a written acknowledgement that such claim is an indemnifiable claim under this Article VII within such twenty (20) days, the Covered Party shall have the right to undertake the defense, compromise or settlement of the claim but shall not thereby waive any right to indemnity therefor pursuant to this Agreement. The Indemnifying Party shall not, except with the consent of the Covered Party, enter into any settlement that is not exclusively monetary paid entirely by the Indemnifying Party and does not include as an unconditional term thereof the giving by the person or persons asserting such claim

 

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to all Covered Parties of an unconditional release from all liability with respect to such claim or consent to entry of any judgment. Notwithstanding the foregoing, the Indemnifying Party shall not be entitled to control any claim relating to Taxes of Buyer or its Subsidiaries, or the Group Companies for any Tax period ending after the Closing Date and shall not be entitled to settle, either administratively or after the commencement of litigation, any claim for Taxes which could adversely affect the liability of Buyer or its Subsidiaries, or the Group Companies for Taxes for any Tax period (or portion thereof) after the Closing Date, without the prior written consent of Buyer.

7.5. Limitations on Indemnity; Payments Out of Subsequent Consideration .

(a) Notwithstanding anything expressed or implied in this Article VII to the contrary, no Covered Party shall be entitled to make a claim for indemnification pursuant to Sections 7.2(a)(i)(v) , 7.2(a)(ii)(x) or 7.2(a)(iii)(x) of this Agreement unless and until the aggregate of all Damages suffered by such Covered Party hereunder exceeds $1,000,000 (the “ Deductible Amount ”), at which point the Covered Party shall only be entitled to indemnification for amounts in excess of the Deductible Amount. Notwithstanding the foregoing, no Deductible Amount shall apply to (i) the Company’s representations and warranties set forth in Sections 3.1 , 3.2 , 3.3 , 3.4 , 3.11 and 3.23 hereof (ii) any Seller’s representations and warranties set forth in Sections 4.1 , 4.2 , 4.7 , 4.8 , 4.9 , 4.10 , 4.11 , and 4.12 hereof, or (iii) Buyer’s representations and warranties set forth in Sections 5.1 , 5.2 and 5.7 .

(b) In the event of a claim for indemnification or reimbursement under Section 7.2(a)(i) , the amount of the related Damages (after taking into account the limitations of Section 7.5(a) ) shall be paid pursuant to and solely by means of deductions, first, from the Escrow Account and then, to the extent that the amount of the Damages are in excess of the amount available in the Escrow Account or the Escrow Agreement has terminated pursuant to its terms, as an offset against the Subsequent Consideration payments, if any, when payable; provided that with respect to claims for indemnification pursuant to Section 7.2(a)(i)(v) , Damages shall be indemnifiable up to an aggregate maximum amount of $20,000,000 (which amount shall include all deductions from the Escrow Account and offsets against Subsequent Consideration payments); provided , further , however , with respect to claims related to breaches of Seller’s representations and warranties set forth in Section 3.4 , Damages shall be indemnifiable up to an aggregate maximum amount (after taking into account all other claims for indemnification under this Agreement) of up to the aggregate consideration paid by Buyer to the Sellers, and Buyer may seek recovery directly against each Seller up to an amount (after taking into account all other claims for indemnification under this Agreement) equal to the portion of the aggregate consideration paid by Buyer to such Seller pursuant to this Agreement.

(c) In the event of a claim for indemnification or reimbursement under Section 7.2(a)(ii) , the amount of the related Damages (after taking into account the limitations of Section 7.5(a) ) shall be paid directly from the applicable Seller. In addition, Buyer may choose to deduct from the Escrow Amount up to such Seller’s share of the Escrow Amount as set forth on Exhibit 2.3(c) or withhold from the Subsequent Consideration payable to such Seller, if any, up to such Seller’s share of the Subsequent Consideration as set forth on Exhibit 2.3(c) . Each Seller’s liability for payments pursuant to Section 7.2(a)(ii)(x) shall be limited to an aggregate amount (after taking into account all other claims for indemnification under this Agreement) equal to the portion of the aggregate consideration received by Seller pursuant to this Agreement.

 

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(d) In the event of a claim for indemnification or reimbursement under Section 7.2(a)(iii) , the amount of the related Damages (after taking into account the limitations of Section 7.5(a) ) shall be paid directly by Buyer. Buyer’s liability for payments pursuant to Section 7.2(a)(iii)(x) shall in no event exceed the Transaction Consideration that would have been paid absent such breach.

(e) Notwithstanding anything herein to the contrary, in all cases determining whether there has been a breach of a representation or warranty for purposes of Section 7.2(a)(i)(v) , 7.2(a)(ii)(x) or 7.2(a)(iii)(x) , or in determining the amount of any Damages with respect to such breach, such representations and warranties (other than the representations and warranties in Sections 3.6(x) , 3.7 , 3.9 , 3.17 and 3.24 ) shall be read without regard to any materiality qualifier (including, without limitation, any reference to Material Adverse Effect) contained therein.

(f) To the extent permitted by Applicable Law, any payment made by a Person indemnifying a Covered Party pursuant to this Article VII shall be treated on the Parties’ Tax Returns as an adjustment to the Transaction Consideration for all Tax purposes.

(g) Any payment of Damages made pursuant to this Article VII shall be paid by the Indemnifying Party without reduction for any tax benefits available to the Covered Party. To the extent that the Covered Party recognizes tax benefits as a result of any payment of Damages made pursuant to this Article VII , the Covered Party shall pay the amount of such tax benefits (but not in excess of such payment of Damages made pursuant to this Article VII ) to the Indemnifying Party as such tax benefits are actually recognized by the Covered Party. For this purpose, the Covered Party shall be deemed to recognize a tax benefit with respect to a taxable year if, and to the extent that, the Covered Party’s cumulative liability for Taxes through the end of such taxable year, calculated by excluding any Tax items attributable to the payment of Damages made pursuant to this Article VII from all taxable years, exceeds the Covered Party’s actual cumulative liability for Taxes through the end of such taxable year, calculated by taking into account any Tax items attributable to the payment of Damages made pursuant to this Article VII for all taxable years (to the extent permitted by relevant Tax law and treating such Tax items as the last items claimed for any taxable year).

7.6. Remedies . The remedies in this Article VII shall be the sole and exclusive remedies of the Parties with respect to any breach of the respective representations, warranties, covenants and agreements pursuant to this Agreement or otherwise arising out of this Agreement, regardless of the theory or cause of action pled, except for the remedies of specific performance, injunction and other equitable relief; provided , however , that no Party hereto shall be deemed to have waived any rights, claims, causes of action or remedies if and to the extent actual fraud is proven on the part of a Party by another Party hereto or such rights, claims, causes of action or remedies may not be waived under Applicable Law.

 

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ARTICLE VIII.

MISCELLANEOUS

8.1. Binding Effect; Assignment . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and permitted assigns, in accordance with the terms hereof. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned by any of the Parties hereto, in whole or in part (whether by operation of law or otherwise), without the prior written consent of the other Parties, and any attempt to make any such assignment without such consent shall be null and void, except that (a) Buyer may assign, in its sole discretion, any or all of its rights, interests and obligations under this Agreement to any entity that is wholly-owned directly by Buyer without the consent of the Parties hereto, but no such assignment shall relieve Buyer of its rights, interests and obligations under this Agreement, (b) Buyer may assign, in its sole discretion, any or all of its rights, interests and obligations under this Agreement to any entity that will acquire substantially all of Buyer’s assets by merger, stock purchase, asset purchase or otherwise without the consent of the Parties hereto, but no such assignment shall relieve Buyer of its rights, interests and obligations under this Agreement, and (c) each Seller may assign, in its sole discretion, any or all of its rights, interests and obligations under this Agreement to any Person in connection with a Permitted Transfer without the consent of the Parties hereto, but no such assignment shall relieve such Seller of its rights, interests and obligations under this Agreement related to the Subsequent Consideration; provided , however , no Seller may assign its rights under Section 6.5 . Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns, and no other Person shall have any right, benefit or obligation hereunder.

8.2. Notices . Unless otherwise provided herein, any notice, request, instruction or other document to be given hereunder by any Party to the other shall be in writing and delivered in person or by courier, by facsimile transmission or mailed by registered or certified mail, postage prepaid, return receipt requested (such mailed notice to be effective on the date of such receipt is acknowledged), as follows:

If to Buyer:

Clovis Oncology, Inc.

2525 28th Street, Suite 100

Boulder, CO 80301

Attn: Patrick J. Mahaffy

Fax: (303) 245-0361

With a copy (which shall not constitute notice) to:

Willkie Farr & Gallagher LLP

787 Seventh Avenue

New York, NY 10019

Attention: William H. Gump

                 Thomas Mark

Fax: (212) 728-8111

 

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If to the Company prior to the Closing:

EOS (Ethical Oncology Science) S.p.A

Via Monte di Pieta n. 1/A

20121 Milano

Attn: Silvano Spinelli

Fax: +39 02 87391617

With a copy (which shall not constitute notice) to:

Shearman & Sterling LLP

Four Embarcadero Center

San Francisco, CA 94111-5994

Attn: Michael J. Kennedy and Jeffrey C. Wolf

Fax: (415) 616-1448

If to the Sellers’ Representative:

Sofinnova Capital V FCPR

c/o Sofinnova Partners SA

Immeuble le Centorial

16-18 rue du Quatre-Septembre

75002 Paris, France

Attn: Antoine Papiernik and Monique Saulnier

Fax: +33 1 53 05 41 29

With a copy (which shall not constitute notice) to:

Shearman & Sterling LLP

Four Embarcadero Center

San Francisco, CA 94111-5994

Attn: Michael J. Kennedy and Jeffrey C. Wolf

Fax: (415) 616-1448

and

Nixon Peabody

401 9 th Street NW

Washington, DC 20004-2128

Attn: John C. Partigan

Fax: 866-947-3586

Any Party may, from time to time, by notice pursuant to this Section 8.2 , designate any other address to which any such notice to such Party shall be sent; provided that any such notice shall be deemed to have been delivered upon receipt.

 

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8.3. Choice of Law . This Agreement shall be construed, interpreted and the rights of the Parties determined in accordance with the laws of the State of New York, as applied to agreements among New York residents entered into and wholly to be performed within the State of New York (without reference to any choice of law rules that would require the application of the laws of any other jurisdiction).

8.4. Entire Agreement; Amendments and Waivers . This Agreement, together with the other documents and instruments referred to herein and all exhibits and schedules hereto, constitutes the entire agreement among the Parties pertaining to the subject matter hereof and supersedes all prior agreements, understandings, negotiations and discussions, whether oral or written, of the Parties. This Agreement may be amended or modified only by a written agreement executed and delivered by duly authorized officers of Buyer and the Sellers’ Representative. This Agreement may not be modified or amended except as provided in the immediately preceding sentence and any purported amendment by any Party or Parties effected in a manner which does not comply with this Section 8.4 shall be void. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provision hereof (whether or not similar), nor shall such waiver constitute a continuing waiver unless otherwise expressly provided.

8.5. Counterparts . This Agreement may be executed by facsimile and in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

8.6. Severability . If any provision of this Agreement is deemed or held to be illegal, invalid or unenforceable, this Agreement shall be considered divisible and inoperative as to such provision to the extent it is deemed to be illegal, invalid or unenforceable, and in all other respects this Agreement shall remain in full force and effect; provided , however , that if any provision of this Agreement is deemed or held to be illegal, invalid or unenforceable the Parties agree to replace such illegal, invalid or unenforceable provision with a provision that is legal, valid and enforceable that achieves the original intent of the Parties as closely as possible. Further, should any provision contained in this Agreement ever be reformed or rewritten by any judicial body of competent jurisdiction, such provision as so reformed or rewritten shall be binding upon all Parties hereto.

8.7. Headings . The headings of the Articles and Sections herein are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

8.8. Schedules . The schedules and the exhibits referenced in this Agreement are a material part hereof and shall be treated as if fully incorporated into the body of the Agreement.

8.9. No Third Party Beneficiaries . Except as provided in Section 6.8 , nothing expressed or referred to in this Agreement shall be construed to give any Person other than the Parties to this Agreement (and their successors and assigns) any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement.

 

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8.10. Specific Performance . The Parties hereto agree that irreparable damage would occur in the event any provision of this Agreement was not performed in accordance with the terms hereof and that the Parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy at law or equity without the necessity of demonstrating the inadequacy of monetary damages or posting bond with respect thereto.

8.11. No Strict Construction . The Parties hereto have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.

8.12. Expenses . Except as otherwise specifically provided in this Agreement, (a) Buyer shall pay its own fees and expenses incurred in connection with this Agreement and the transactions contemplated hereby, (b) the Sellers shall pay their own fees and expenses incurred in connection with this Agreement and the transactions contemplated hereby, and (c) the aggregate Transaction Expenses of the Group Companies due and payable prior to the Closing which remain unpaid at the Closing shall be paid by Buyer.

8.13. Arbitration .

(a) Each of the Parties agrees that any claims, disputes or disagreements arising under, or in connection with this Agreement including without limitation the construction, performance or breach of this Agreement will be referred exclusively to, and shall be finally settled by, a tribunal of arbitrators which will apply the Rules of the International Chamber of Commerce (ICC) which are deemed to form part of this Agreement.

(b) There shall be three arbitrators, one selected by the party initiating the arbitration (either Sellers’ Representative on behalf of Sellers or Buyer, as applicable) in the request for arbitration, the second selected by mutual agreement of the other party (either Sellers’ Representative on behalf of Sellers or Buyer, as applicable) within 20 days of the delivery of the request for arbitration, and the third (who shall act as chairperson of the arbitration tribunal) selected by the two party appointed arbitrators within 20 days of the selection of the second arbitrator. In the event that the respondent fails to select an arbitrator, or if the two party appointed arbitrators are unable or fail to agree upon the third arbitrator, the International Court of Arbitration of the International Chamber of Commerce shall designate the remaining arbitrator(s) required to comprise the tribunal. The claimant in the arbitration shall provide a copy of the request for arbitration to the respondent at the time such request is submitted to the Secretariat of the International Chamber of Commerce.

(c) The place of arbitration shall be London, United Kingdom. The language of the arbitral proceedings and of all submissions and written evidence shall be English; provided , however, that a Party, at its expense, may provide for translation or simultaneous interpretation into a language other than English.

(d) The arbitrators shall issue an award within nine months of the submission of the request for arbitration of any dispute.

 

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(e) It is expressly understood and agreed by the parties that the rulings and award of the tribunal shall be conclusive and binding on the parties, their successors and permitted assigns. Judgment on the award rendered by the tribunal may be entered in any court having jurisdiction thereof.

(f) The parties agree that any arbitration shall be conducted in a confidential manner. The parties shall (i) not publicly disclose any information regarding the arbitration or any award issued in the arbitration, except as may be required by Applicable Law; and (ii) keep all material used or exchanged in the arbitration confidential and agree that any such material shall be used solely for the purposes of the arbitration, and shall not be used for any business, commercial, competitive or other purpose.

(g) The party that does not prevail in the arbitration proceeding shall pay the arbitrator’s fees and any administrative fees of arbitration.

[remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement or caused this Agreement to be duly executed on their respective behalf, by their respective officers thereunto duly authorized, all as of the day and year first above written.

 

CLOVIS ONCOLOGY, INC.

 

By:  

/s/ Patrick J. Mahaffy

Name:   Patrick J. Mahaffy
Title:   President and Chief Executive Officer


EOS (ETHICAL ONCOLOGY SCIENCE) S.P.A.

 

By:  

/s/ Silvano Spinelli

Name:   Silvano Spinelli
Title:   Chief Executive Officer


Luxcapital V. S.a.r.l.
By:  

/s/ Antoine Papiernik

Name:   Antoine Papiernik
Title:   Managing Partner of Sofinnova Partners

Cooperatieve Aescap Venture I U.A. (cooperative association)

By:  

/s/ Domenico Valerio

Name:   Domenico Valerio
Title:   Authorized Signatory

Principia S.g.r. - Società di gestione del risparmio S.p.A.

By:  

/s/ Roberto Mazzei

Name:   Roberto Mazzei
Title:   Chairman

 

/s/ Silvano Spinelli

Name:   Silvano Spinelli

 

/s/ Maria Gabriella Camboni

Name:   Maria Gabriella Camboni

 

/s/ Ennio Cavalletti

Name:   Ennio Cavalletti

 

/s/ Huh Hoyoung

Name:   Huh Hoyoung

 

/s/ Jacques Theurillat

Name:   Jacques Theurillat

 

/s/ Roberta Cereda

Name:   Roberta Cereda


SELLERS’ REPRESENTATIVE:
SOFINNOVA CAPITAL V FCPR
By:   Sofinnova Partners SAS
By:  

/s/ Antoine Papiernik

Name:   Antoine Papiernik
Title:   Managing Partner of Sofinnova Partners

Exhibit 4.1

REGISTRATION RIGHTS AGREEMENT

REGISTRATION RIGHTS AGREEMENT, dated as of November 19, 2013 (this “ Agreement ”), by and between Clovis Oncology, Inc., a Delaware corporation (the “ Company ”), EOS (Ethical Oncology Science) S.p.A., an Italian corporation (“ EOS ”), each of the Persons listed on Exhibit A hereto (the “ Shareholders ”);

WHEREAS, the Company purchased all of the issued and outstanding capital stock of EOS pursuant to that certain Stock Purchase Agreement, dated as of November 19, 2013 (the “ Stock Purchase Agreement ”), between the Company, EOS, the Shareholders and the Shareholders’ Representative;

WHEREAS, pursuant to the Stock Purchase Agreement, the Shareholders are receiving cash in the amount of $10,000,000 and a total amount of 3,713,731 shares of common stock of the Company, par value $.001 per share (“ Clovis Common Stock ”), issued by the Company;

WHEREAS, the issuance of the shares to the Shareholders by the Company pursuant to the Stock Purchase Agreement has not been registered under applicable United States federal securities laws and, therefore, the shares of Clovis Common Stock that each Shareholder acquires pursuant to the Stock Purchase Agreement will be “restricted securities” under such federal securities laws; and

WHEREAS, the Company has agreed to provide the registration rights provided for in this Agreement to the Shareholders with respect to all of the Registrable Securities (as hereinafter defined);

NOW, THEREFORE, in consideration of the premises and the covenants hereinafter contained and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, it is agreed as follows:

1. Definitions . Unless otherwise defined herein, the terms below shall have the following meanings (such meanings being equally applicable to both the singular and plural form of the terms defined):

Automatic Shelf Registration Statement ” shall have the meaning given thereto pursuant to Rule 405 promulgated under the Securities Act.

Acquisition Transaction ” means the transactions contemplated by the Stock Purchase Agreement.

Affiliate ” shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by or is under common control with such Person.

Agreement ” shall mean this Registration Rights Agreement, including all amendments, modifications and supplements and any exhibits or schedules to any of the foregoing.


Business Day ” shall mean any day that is not a Saturday, a Sunday or a day on which commercial banks are required or permitted by law to be closed in the City of New York in the State of New York or Milan, Italy.

Change of Control ” means the acquisition of the Company by another entity by means of any transaction or series of related transactions (including, without limitation, any stock acquisition, reorganization, merger or consolidation, but excluding any sale of stock for capital raising purposes) other than a transaction or series of related transactions (a) in which the holders of the voting securities of the Company outstanding immediately prior to such transaction continue to retain (either by such voting securities remaining outstanding or by such voting securities being converted into voting securities of the surviving entity), as a result of shares in the Company held by such holders prior to such transaction, at least fifty percent (50%) of the total voting power represented by the outstanding voting securities of the Company or such other surviving or resulting entity (or if the Company or such other surviving or resulting entity is a wholly-owned subsidiary immediately following such acquisition, its parent) immediately after such transaction, or (b) after which the Shareholders own securities of the Company or the other surviving or resulting entity, as a result of shares in the Company held by such Shareholders prior to such transaction, that are not freely tradable under federal securities laws.

Closing Date ” shall mean the date on which the closing of the Acquisition Transaction occurs.

Control ” (including the terms “ Controlled by ” and “ under common Control with ”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, as trustee or executor, by contract or otherwise, including, without limitation, the ownership, directly or indirectly, of securities having the power to elect a majority of the board of directors or similar body governing the affairs of such Person.

Exchange Act ” shall mean the Securities Exchange Act of 1934, as amended, and all rules and regulations promulgated thereunder.

Indemnified Party ” shall mean a Person entitled to be indemnified pursuant to Section 10(a) or (b) .

Indemnifying Party ” shall mean a party obligated to indemnify another Person pursuant to Section 10(a) or (b) .

Initial Liquidity Period ” means the period commencing on the date on which the Shelf Registration Statement first becomes effective under the Securities Act and ending on December 18, 2013 or such earlier date upon which the closing of an underwritten offering pursuant to Section 3 hereof occurs.

Majority Holders ” shall mean the holders of the majority of Registrable Securities.

 

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Permitted Transferee ” means (a) if such Shareholder is an individual: (i) such Shareholder’s immediate family or a trust or other estate planning vehicle established for the benefit of such Shareholder or any member of such Shareholder’s immediate family, or (ii) upon the death of such Shareholder, such Shareholder’s heirs, (b) if such Shareholder is a partnership, limited liability company or similar entity: (i) its partners or members (in a pro rata distribution), (ii) an affiliated corporation, trust or other business entity under common control with such Shareholder, or (iii) if such Shareholder is a trust, to a beneficiary thereof, or (c) if such Shareholder is a corporation or similar entity: (i) its shareholders or stakeholders (in a pro rata distribution) or (ii) its Affiliates.

Person ” shall mean any individual, corporation, partnership, limited liability company, joint venture, firm, trust, unincorporated organization, government or any agency or political subdivision thereof or other entity.

Prospectus ” shall mean any prospectus included in any Registration Statement, as amended or supplemented in any manner, including any prospectus or supplement filed pursuant to Rule 424 under the Securities Act and any free-writing prospectus approved by the Company, including in each case all material incorporated by reference therein.

Registrable Securities ” shall mean (a) the shares of Clovis Common Stock issued pursuant to the Stock Purchase Agreement and held by a Shareholder and (b) any securities issuable or issued or distributed in respect of any of the Clovis Common Stock identified in clause (a) by way of stock dividend or stock split or in connection with a combination of shares, recapitalization, reorganization, merger, consolidation or otherwise. For purposes of this Agreement, Registrable Securities shall cease to be Registrable Securities when such Registrable Securities: (i) have been disposed of pursuant to a Registration Statement, (ii) are sold pursuant to Rule 144, (iii) with respect to any holder of Registrable Securities, the first day when all Registrable Securities held by such holder could be sold pursuant to Rule 144 during any 90 day period without relying on the Company maintaining current public information as defined in Rule 144, (iv) shall have been otherwise transferred and new certificates for them not bearing a legend restricting further transfer shall have been delivered by the Company, or (v) cease to be outstanding.

Registration Statement ” shall mean the Shelf Registration Statement or any Subsequent Registration Statement, together with all amendments and supplements thereto, filed with the SEC to effect the Shelf Registration.

Rule 144 ” means Rule 144 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such rule.

SEC ” shall mean the Securities and Exchange Commission, or any successor thereto.

Securities Act ” shall mean the Securities Act of 1933, as amended, and all rules and regulations promulgated thereunder.

 

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Shareholder ” shall mean a Shareholder, and any holder of Registrable Securities to whom the registration rights conferred by this Agreement have been validly transferred in accordance with the terms of this Agreement, and, in each case, who continues to be entitled to the rights of a Shareholder hereunder.

Shelf Registration ” shall mean the registration under the Securities Act of the resale of any or all of the Registrable Securities in accordance with methods and distribution set forth in the “Plan of Distribution” section in the Shelf Registration Statement, and Rule 415 under the Securities Act.

Shelf Registration Statement ” shall mean a registration statement on Form S-3 to effect the Shelf Registration, in substantially the form provided to EOS and the Shareholders prior to the consummation of the Acquisition Transaction, together with all subsequent amendments and supplements thereto.

Subsequent Registration Statement ” shall have the meaning given thereto in Section 2(b) .

Transaction 8-K ” shall mean a Form 8-K of the Company with respect to the Acquisition Transaction containing all information required to be contained therein, including any financial statements of EOS and any pro forma financial information, and all required exhibits thereto, in substantially the form provided to EOS and the Shareholders prior to the consummation of the Acquisition Transaction.

Well-Known Seasoned Issuer ” shall have the meaning given thereto pursuant to Rule 405 promulgated under the Securities Act.

2. Shelf Registration .

(a) Prior to the Closing Date, the Company shall prepare the Transaction Form 8-K and the Shelf Registration Statement. On the Closing Date and promptly following the consummation of the closing of the Acquisition Transaction, the Company shall file the Transaction 8-K with the SEC. On the Closing Date and promptly following the filing of the Transaction 8-K with the SEC, the Company shall file the Shelf Registration Statement pursuant to General Instruction I.D. of Form S-3 and otherwise in a manner to cause it to be an Automatic Shelf Registration Statement. The Company hereby represents to the Shareholders that it is a Well-Known Seasoned Issuer and eligible to use Form S-3 and that the Shelf Registration Statement will become effective upon the filing thereof with the SEC. The Registration Statement shall contain a Prospectus naming the Shareholders as selling stockholders, and the Company hereby consents to the use from time to time of the then-current Prospectus by each of the Shareholders in connection with the offering and sale of the Registrable Securities covered by the Registration Statement.

(b) During the Initial Liquidity Period, the Company shall use its reasonable best efforts to keep the Registration Statement continuously effective for as long as there shall be any Registrable Securities and shall prepare and file with the SEC such amendments and supplements to the Registration Statement and the Prospectus used in connection therewith as may be necessary to keep the Registration Statement effective and the Prospectus from

 

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containing any untrue statement of material fact or omitting to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of all circumstances then existing. Following the Initial Liquidity Period, the Company shall use commercially reasonable efforts to keep the Registration Statement continuously effective for as long as there shall be any Registrable Securities and shall use commercially reasonable efforts to prepare and file with the SEC such amendments and supplements to the Registration Statement and the Prospectus used in connection therewith as may be necessary to keep the Registration Statement effective and the Prospectus from containing any untrue statement of material fact or omitting to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of all circumstances then existing; provided , however , after the end of the Initial Liquidity Period the Company may delay the filing of any such amendment or supplement for up to ninety (90) days upon notice to the Shareholders in the event that the Company determines in good faith that such amendment or supplement would require the Company to make a disclosure that would be materially detrimental to the Company; provided , that such right to delay a filing shall be exercised by the Company for a period no longer than ninety (90) days in any 12-month period; provided further that in the event of such a delay, each Shareholder shall keep confidential the fact that such delay is in effect unless and until otherwise notified by the Company, except (A) for disclosure to such Shareholder’s employees, agents and professional advisers who reasonably need to know such information for purposes of assisting the Shareholder with respect to its investment in the Clovis Common Stock and who agree to keep it confidential and (B) as required by law, rule or regulation. Without limiting the generality of the foregoing, if the Registration Statement is an Automatic Shelf Registration Statement at any time the Company is required to re-evaluate its Well-Known Seasoned Issuer status and the Company determines that it no longer is a Well-Known Seasoned Issuer, the Company shall immediately amend the Registration Statement to convert it to the form of registration statement that the Company is then eligible to use.

(c) The Company shall use commercially reasonable efforts to obtain the prompt withdrawal of any order suspending the effectiveness of such Registration Statement, and amend such Registration Statement in a manner reasonably expected to obtain the withdrawal of any order suspending the effectiveness of such Registration Statement or file an additional or replacement registration statement providing for the Shelf Registration (a “ Subsequent Registration Statement ”); provided that no Subsequent Registration Statement shall provide for the registration of any securities other than the Registrable Securities. Prior to the expiration of any Registration Statement, the Company shall file a Subsequent Registration Statement so as to prevent any disruption of or lapse in the Shelf Registration. If a Subsequent Registration Statement is filed, the Company shall use commercially reasonable efforts to (x) cause such Subsequent Registration Statement to become effective under the Securities Act as soon as reasonably practicable after such filing and (y) keep such Subsequent Registration Statement (or another Subsequent Registration Statement) continuously effective with the SEC at all times for so long as there shall be any Registrable Securities; provided , however , after the end of the Initial Liquidity Period, the Company may delay the filing of such Subsequent Registration Statement for up to ninety (90) days in the event that the Company determines in good faith that filing such Subsequent Registration Statement would require the Company to make a disclosure that would be materially detrimental to the Company; provided , that such right to delay shall be exercisable by the Company for a period no longer than ninety (90) days in any 12-month period; provided further that in the event of such a delay, each Shareholder shall keep confidential the fact that a

 

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delay is in effect unless and until otherwise notified by the Company, except (A) for disclosure to such Shareholder’s employees, agents and professional advisers who reasonably need to know such information for purposes of assisting the Shareholder with respect to its investment in the Clovis Common Stock and who agree to keep it confidential and (B) as required by law, rule or regulation. Any such Subsequent Registration Statement shall be a registration statement on Form S-3 to the extent that the Company is eligible to use such form and, if the Company is a Well-Known Seasoned Issuer at the time of the filing thereof, shall be filed pursuant to General Instruction I.D. of Form S-3 and otherwise in a manner to cause it to be an Automatic Shelf Registration Statement.

(d) If requested by a Shareholder and not already reasonably covered by the disclosure in the Prospectus, the Company shall (i) as soon as reasonably practicable incorporate in a prospectus supplement or post-effective amendment such information as is reasonably required to be included therein relating to any proposed sale and distribution of Registrable Securities by such Shareholder, including, without limitation, information with respect to the number of Registrable Securities being offered or sold, the purchase price being paid therefor and any other terms of the offering of the Registrable Securities to be sold in such offering, and (ii) as soon as reasonably practicable make all required filings of such prospectus supplement or post-effective amendment after being notified of the matters to be incorporated in such prospectus supplement or post-effective amendment. If requested by a Shareholder who is a transferee of Registrable Securities, the Company shall as soon as reasonably practicable incorporate in a prospectus supplement or post-effective amendment such information as is reasonably required to add such Shareholder as a selling shareholder in the Prospectus in the place of the transferor Shareholder.

(e) The rights set forth herein in this Section 2, Section 3, Section 4 and Section 6 shall terminate and cease to be available as to any Shareholder at such time as such Shareholder first ceases to own any Registrable Securities.

(f) From the date hereof until the earlier of (x) the date upon which the closing of an underwritten offering pursuant to Section 3 hereof occurs and (y) January 31, 2014, the Company will not, and will instruct its directors, officers, employees, financial advisors, legal counsel, auditors, accountants or other agents not to, directly or indirectly take any action to initiate or pursue any material acquisition, joint venture, financing or similar transaction if doing so would cause the Prospectus to contain any untrue statement of material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of all circumstances then existing if the disclosure of such transaction would be materially detrimental to the Company; provided , nothing in this Section 2(f) shall preclude the Company or any of its agents from responding to a bona fide unsolicited proposal or tender offer or otherwise pursuing or proceeding therewith.

3. Underwriting .

(a) If LuxCapital V. S.a.r.l. (the “ Initiating Holder ”) intends that any of its Registrable Securities shall be distributed by means of an underwritten public offering, such Initiating Holder will so advise the Company and provide notice to the other Shareholders who may then elect by written notice to the Company and the Initiating Holder to include their

 

6


Registrable Securities in such underwritten offering (such Shareholders and the Initiating Holder, the “ Participating Holders ”). In such event, the managing underwriter to administer the offering will be chosen by mutual agreement of the Participating Holders holding a majority of the Registrable Securities then held by all Participating Holders and the Company. Unless otherwise mutually agreed by the Company and the Participating Holders, the Company and the Participating Holders shall enter into an underwriting agreement in such reasonable and customary form as shall have been negotiated and agreed to by the Company with the underwriter or underwriters selected for such underwriting. If the Participating Holders disapprove of the terms of the underwriting, the Participating Holders may promptly elect to withdraw therefrom by written notice to the Company and the managing underwriter. If the managing underwriter in any underwritten offering pursuant to this Section 3 advises the Company that in its reasonable opinion the number of securities requested by the Participating Holders to be included in such distribution exceeds the number which can be sold without adversely affecting the marketability of such offering (including an adverse effect on the per share offering price), the Participating Holders will include, on a pro rata basis, in such distribution only such number of securities that in the reasonable opinion of such underwriter can be sold without adversely affecting the marketability of the offering (including an adverse effect on the per share offering price).

(b) The Company shall not be obligated to effect, or to take any action to effect, any underwritten public offering pursuant to this Section 3 :

(i) If the Initiating Holder proposes to sell Registrable Securities the aggregate gross proceeds of which would be less than $50,000,000 based on the market price of Clovis Common Stock at the time the Initiating Holder gives notice to the Company to initiate such underwritten public offering;

(ii) After one underwritten public offering contemplated by this Section 3 has been successfully consummated; or

(iii) During the period starting with the later of January 31, 2014 and the date that is sixty (60) days prior to the Company’s good faith estimate of the date of a public offering by the Company of its securities and ending on the date on which all market stand-off agreements applicable to the offering have terminated but not later than one hundred eighty (180) days after the closing of such public offering; provided that throughout such period the Company is actively employing in good faith commercially reasonable efforts to undertake such offering.

(c) If at any time after the end of the Initial Liquidity Period (i) in the good faith judgment of the Company, the undertaking of such an offering would be materially detrimental to the Company and the Company concludes, as a result, that it is in the best interests of the Company to defer such offering at such time, and (ii) the Company shall furnish to the Initiating Holder a certificate signed by the President of the Company stating that in the good faith judgment of the Company, it would be materially detrimental to the Company for such offering to be undertaken in the near future and that it is, therefore, in the best interests of the Company to defer such offering, then the Company shall have the right to defer the undertaking of such an offering for a period of

 

7


not more than ninety (90) days after receipt of the request of the Initiating Holder, and, provided , that the Company shall not defer its obligation in this manner for more than a total of ninety (90) days in any twelve-month period; provided further that in the event of such a deferral, each Shareholder shall keep confidential the fact that a delay is in effect unless and until otherwise notified by the Company, except (A) for disclosure to such Shareholder’s employees, agents and professional advisers who reasonably need to know such information for purposes of assisting the Shareholder with respect to its investment in the Clovis Common Stock and who agree to keep it confidential and (B) as required by law, rule or regulation.

4. Registration Procedures . The Company shall, as expeditiously as possible:

(a) furnish to the Shareholders such number of conformed copies, without charge, of the applicable Registration Statement and each amendment and supplement thereto (including in each case all exhibits), and such other documents necessary for the resale of Registrable Securities pursuant to the Prospectus, as such selling Shareholders may reasonably request;

(b) promptly deliver to each Shareholder, upon written request of such Shareholder, without charge except as provided below, as many copies of the then-current form of the Prospectus as such Shareholder may reasonably request in connection with re-sales by such Shareholder of Registrable Securities; provided that printing expenses incurred in connection with the delivery of Prospectuses by underwriters pursuant to an underwritten public offering contemplated by Section 3 shall be borne by the Participating Holders;

(c) use commercially reasonable efforts to register or qualify the securities covered by the Registration Statement, and keep such registration or qualification effective, under such other securities or blue sky laws of such jurisdictions within the United States as each Shareholder shall reasonably request, and to take any other action which may be reasonably necessary to enable such Shareholder to consummate the disposition in such jurisdictions of the securities owned by such Shareholder; provided , however , that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business, subject itself to taxation in or file a general consent to service of process in any jurisdiction wherein it would not but for the requirements of this paragraph (d) be obligated to do so;

(d) give prompt written notice to the Shareholders:

(i) when any amendment to the Registration Statement has been filed with the SEC and when any post-effective amendment thereto has become effective;

(ii) of any request by the SEC for amendments or supplements to the Registration Statement or the Prospectus or for additional information;

 

8


(iii) of the issuance by the SEC of any stop order suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose;

(iv) of the receipt by the Company or its legal counsel of any written notification with respect to the suspension of the qualification of the Registrable Securities for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; and

(v) of the happening of any event that requires the Company to make an amendment or supplement to the Registration Statement or the Prospectus so that they do not contain any untrue statement of material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading (in the case of the Prospectus, in light of the circumstances under which they were made);

(e) make reasonably available for inspection by the representatives of the Participating Holders, any underwriter participating in any disposition pursuant to such Registration Statement and any attorney, accountant or other agent retained by the Initiating Holder or any such underwriter all relevant financial and other records, pertinent corporate documents and properties of the Company and cause the Company’s officers, directors and employees to supply all relevant information reasonably requested by such representative or any such underwriter, attorney, accountant or agent for purposes of conducting customary due diligence in connection with the filing of the Registration Statement and any underwritten public offering contemplated by Section 3;

(f) in connection with any underwritten offering, negotiate in good faith and enter into an underwriting agreement with the underwriter or underwriters selected for such underwriting in a form reasonable and customary for transactions of the type of the underwritten offering;

(g) in connection with any underwritten offering, use commercially reasonable efforts to obtain and deliver to the underwriters one or more comfort letters, addressed to the underwriters, dated the date of the underwriting agreement and the date of the closing under the underwriting agreement for such offering, signed by the Company’s independent registered public accountants (and if necessary, any other independent registered public accountants of any business acquired by the Company for which financial statements and financial data are, or are required to be, included in the Registration Statement) in customary form and covering such matters of the type customarily covered by comfort letters as such underwriters shall reasonably request;

(h) in connection with any underwritten offering, use commercially reasonable efforts to provide to the underwriters legal opinions of the Company’s counsel, addressed to the underwriters, dated the date of closing under the underwriting agreement, with respect to the Registration Statement, each amendment and supplement thereto, the Prospectus and such other documents relating thereto as the underwriter shall reasonably request in customary form and covering such matters of the type customarily covered by legal opinions of such nature;

 

9


(i) in connection with any underwritten offering, make appropriate officers of the Company reasonably available to the underwriters for meetings with prospective purchasers of the Registrable Securities and prepare and present to potential investors customary “road show” material in each case in accordance with the recommendations of the underwriters and in all respects in a manner consistent with other issuances of securities in an offering of a similar size to such offering of the Registrable Securities; and

(j) instruct its transfer agent to remove any restrictive legend on Registrable Securities upon notice that such Registrable Securities have been sold under the Registration Statement and shall deliver a new certificate for such Registrable Securities not bearing any restrictive legend promptly and, in any case, no later than two business days after the giving of such notice.

5. Expenses . All expenses incurred in connection with the Shelf Registration and the performance by the Company of its obligations under this Agreement with respect to the Shelf Registration, excluding underwriters’ discounts and commissions, but including without limitation all registration, filing and qualification fees, word processing, duplicating, printers’ and accounting fees, listing fees, messenger and delivery expenses, all fees and expenses of complying with state securities or blue sky laws, fees and disbursements of counsel for the Company shall be paid by the Company, except that the Shareholders shall bear and pay the underwriting discounts, selling commissions and discounts in connection with any registrations, filings and qualifications made pursuant to this Agreement, any stock transfer taxes applicable to the sale of Registrable Securities and any fees and expenses incurred in respect of counsel or other advisors to the Shareholders; provided , however , notwithstanding the foregoing but subject to the limitations set forth below, all reasonable out-of-pocket expenses incurred in connection with an underwritten offering contemplated hereby (whether or not incurred by the Company) shall be paid by the Participating Holders, including but not limited to: the costs of printing and distributing any Prospectus used in the underwritten offering, fees and disbursements of counsel for the underwriters (if payable by the Company or the Participating Holders), counsel for the Company and counsel for the Participating Holders, all accounting fees (including the expenses of any “comfort” letters) (provided that the expenses with respect to (x) fees and disbursements to counsel to the Company and (y) accounting fees (including the expenses of any “comfort” letters) shall not exceed $160,000 in the aggregate), all out-of-pocket costs and expenses incurred by the Company or its officers in attending “road show” presentations and similar marketing activities, underwriting discounts, selling commissions and discounts, and any stock transfer taxes applicable to the sale of Registrable Securities. To the extent that any expenses which the Participating Holders are required to pay in connection with the underwritten offering remain unreimbursed or unpaid as of the closing of the underwritten offering, the Company and the Participating Holders shall direct the underwriters to deliver to an account identified by the Company at the closing of the underwritten offering, by wire transfer of immediately available funds, the portion of the proceeds from the underwritten offering representing such unpaid and unreimbursed expenses.

 

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6. Rule 144 Information .

For twelve (12) months from the date hereof, the Company will use commercially reasonable efforts to timely file all reports and other documents required to be filed by it under the Securities Act and the Exchange Act (or, if the Company is not required to file such reports, it will, upon the request of the Majority Holders, make publicly available such information as necessary to permit sales pursuant to Rule 144 or Regulation S under the Securities Act), to the extent required from time to time to enable the Shareholders to sell shares of Registrable Securities without registration under the Securities Act within the limitation of the exemptions provided by (i) Rule 144 or Regulation S under the Securities Act, as such rules may be amended from time to time, or (ii) any similar rule or regulation hereafter adopted by the SEC. For twelve (12) months from the date hereof, upon the reasonable request of a Shareholder selling pursuant to Rule 144, the Company will deliver to such Shareholder a written statement as to whether it has complied with such information requirements, and, if not, the specifics thereof.

7. Shareholders.

(a) Each of the Shareholders shall furnish to the Company such information regarding such Shareholder and its partners and members and its controlling Persons, and the manner of distribution proposed by such Shareholder as the Company may reasonably request in writing and as shall be reasonably requested in connection with any registration, qualification or compliance referred to in Section 2 .

(b) Each Shareholder agrees that upon receipt of any notice from the Company of the happening of any event of the kind described in Section 4(d)(v) , such Shareholder shall forthwith discontinue disposition of Registrable Securities pursuant to the Registration Statement and by means of the Prospectus covering such Registrable Securities until such Shareholder’s receipt of the copies of a supplemented or amended Prospectus or until such Shareholder is advised in writing by the Company that the use of the Prospectus may be resumed, and, if so directed by the Company, such Shareholder shall deliver to the Company all copies, other than any permanent file copies then in such Shareholder’s possession, of the most recent Prospectus covering such Registrable Securities at the time of receipt of such notice.

8. Indemnification and Contribution .

(a) To the extent permitted by law, the Company shall indemnify and hold harmless each Shareholder, such Shareholder’s directors and officers and each Person, if any, who controls such Shareholder within the meaning of Section 15 of the Securities Act, against any losses, claims, damages or liabilities, joint or several, to which such Indemnified Party may become subject under the Securities Act or otherwise, insofar as such losses, claims, damages, liabilities (or proceedings in respect thereof), or costs, arise out of or are based on (i) any untrue or alleged untrue statement of any material fact contained in any Registration Statement or Prospectus, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not

 

11


misleading (in the case of the Prospectus, in light of the circumstances under which they were made), (ii) any violation by the Company of the Securities Act, Exchange Act or other federal or state securities law applicable to the Company in connection with the Shelf Registration, any registration or qualification of the Registrable Securities or any resale thereof by the Shareholders pursuant to the Registration Statement and the Prospectus, and the Company shall reimburse each such Person for any reasonable and documented legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided , however , that the indemnity agreement contained in this Section 8(a) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld); provided , further , that the Company shall not be liable to any such Indemnified Party in any such case for any such loss, claim, damage, liability or action to the extent that it arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in connection with such Registration Statement, Prospectus or amendment or supplement thereto, based upon and in conformity with written information furnished expressly for use in connection with such registration by any such Indemnified Party. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of any such Shareholder, such Shareholder’s directors and officers or controlling Person, and shall survive the transfer of such securities by such Shareholder.

(b) To the extent permitted by law, each Shareholder shall indemnify and hold harmless the Company, each of its directors and officers, each Person, if any, who controls the Company within the meaning of Section 15 of the Securities Act and each agent of the Company against any losses, claims, damages or liabilities, joint or several, to which such Indemnified Party may become subject, under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or proceedings in respect thereof) arise out of or are based upon any untrue statement or alleged untrue statement of any material fact contained in any Registration Statement, Prospectus or any amendment or supplement thereto or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading (in the case of the Prospectus, in light of the circumstances under which they were made), in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in such Registration Statement, Prospectus, or amendment or supplement thereto based on and in conformity with written information furnished by or on behalf of such Shareholder expressly for use in connection with such registration; and each such Shareholder shall reimburse any reasonable and documented legal or other expenses reasonably incurred by such Indemnified Party in connection with investigating or defending any such loss, claim, damage, liability or action; provided , however , that the indemnity agreement contained in this Section 8(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of such Shareholder (which consent shall not be unreasonably withheld), and provided , further , that the liability of each Shareholder hereunder shall be limited to the aggregate net proceeds received by such Shareholder in connection with the sale of Registrable Securities by such Shareholder.

(c) If the indemnification provided for in this Section 8 from the Indemnifying Party is held by a court of competent jurisdiction to be unavailable to an Indemnified Party

 

12


hereunder in respect of any losses, claims, damages, liabilities or expenses referred to therein, then the Indemnifying Party, in lieu of indemnifying such Indemnified Party, shall contribute to the amount paid or payable by such Indemnified Party as a result of such losses, claims, damages, liabilities or expenses in such proportion as is appropriate to reflect the relative fault of the Indemnifying party and Indemnified parties in connection with the actions which resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations. The relative fault of such Indemnifying party and Indemnified parties shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact, has been made by, or relates to information supplied by, such Indemnifying party or Indemnified parties, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action. The amount paid or payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include any reasonable and documented legal or other fees or expenses reasonably incurred by such party in connection with any investigation or proceeding. The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 8(c) were determined by pro rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in the immediately preceding paragraph. No Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.

(d) Any Indemnified Party agrees to give prompt written notice to the Indemnifying Party after the receipt by the Indemnified Party of actual knowledge (including by receipt of written notice of the commencement) of any action, suit, proceeding or investigation or threat thereof for which the Indemnified Party intends to claim indemnification or contribution pursuant to this Agreement; provided , that the failure so to notify the Indemnifying Party shall not relieve the Indemnifying Party of any liability that it may have to the Indemnified Party hereunder unless such failure is materially prejudicial to the Indemnifying Party. If notice of commencement of any such action is given to the Indemnifying Party as above provided, the Indemnifying Party shall be entitled, to assume the defense of such action at its own expense, with counsel chosen by it and reasonably satisfactory to such Indemnified Party. The Indemnified Party shall have the right to employ separate counsel in any such action and participate in the defense thereof, but the fees and expenses of such counsel shall be paid by the Indemnified Party unless (i) the Indemnifying Party agrees to pay the same, (ii) the Indemnifying Party fails to assume the defense of such action, or (iii) the named parties to any such action (including any impleaded parties) have been advised by such counsel that either (A) representation of such Indemnified Party and the Indemnifying Party by the same counsel would be inappropriate under applicable standards of professional conduct or (B) there are one or more legal defenses available to it which are substantially different from or additional to those available to the Indemnifying Party; provided that the Indemnifying Party shall not, in connection with any proceeding or related proceeding in the same jurisdiction, be liable for the fees and expenses of more than one separate counsel for all Indemnified Parties. No Indemnifying Party shall be liable for any settlement entered into which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified party of a release from all liability in respect of such proceeding without its written consent, which consent shall not be unreasonably withheld. Each Indemnified Party shall furnish such information regarding

 

13


itself or the claim in question as an Indemnifying Party may reasonably request in writing and as shall be reasonably required in connection with the defense of such claim and proceeding resulting therefrom.

(e) Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in an underwriting agreement entered into in connection with an underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement with respect thereto shall control.

(f) The agreements contained in this Section 8 shall survive the transfer of the Registered Securities by any Shareholder and sale of all the Registrable Securities pursuant to any registration statement and shall remain in full force and effect, regardless of any investigation made by or on behalf of any Shareholder or such director, officer or participating or controlling Person.

9. Miscellaneous .

(a) Specific Performance . The parties hereto agree that irreparable damage would occur in the event any provision of this Agreement was not performed in accordance with the terms hereof and that the parties hereto shall be entitled to specific performance of the terms hereof, in addition to any other remedy at law or in equity.

(b) Amendments and Waivers; Assignment . This Agreement may be amended or modified only by a written agreement executed and delivered by duly authorized officers of the Company and the Majority Holders (which amendments shall be binding on all of the Shareholders to the same extent as if such amendments had been executed by such Shareholder). This Agreement may not be modified or amended except as provided in the immediately preceding sentence and any purported amendment by any party or parties effected in a manner which does not comply with this Section 9(b) shall be void. No waiver of any of the provisions of this Agreement shall be effective unless such waiver is in writing and signed by the party waiving its rights hereunder or, in the case of the Shareholders, the Majority Holders. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provision hereof (whether or not similar), nor shall such waiver constitute a continuing waiver unless otherwise expressly provided.

(c) Notice Generally . Unless otherwise provided herein, any notice, request, instruction or other document to be given hereunder by any party to the other shall be in writing and delivered in person or by courier, by facsimile transmission or mailed by registered or certified mail, postage prepaid, return receipt requested (such mailed notice to be effective on the date of such receipt is acknowledged), as follows:

(i) If to any Shareholder, at its last known address appearing on the books of the Company maintained for such purpose.

 

 

14


(ii) If to the Company, at

Clovis Oncology, Inc.

2525 28th Street, Suite 100

Boulder, CO 80301

Attn: Patrick J. Mahaffy

Fax: (303) 245-0361

With a copy (which shall not constitute notice) to:

Willkie Farr & Gallagher LLP

787 Seventh Avenue

New York, NY 10019

Attention: William H. Gump

                 Thomas Mark

Fax: (212) 728-8111

Any party may, from time to time, by notice pursuant to this Section 10(c) , designate any other address to which any such notice to such party shall be sent; provided that any such notice shall be deemed to have been delivered upon receipt.

(d) Successors and Assigns; Third Party Beneficiaries . This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and permitted assigns, in accordance with the terms hereof. Neither this Agreement nor any right or obligation or any Shareholder hereunder may be assigned in whole or in part without the prior written consent of the Company and any purported assignment in violation of this provision shall be void; provided , however , that the rights and obligations hereunder of any Shareholder may be assigned, in whole or in part, to any Permitted Transferee who is the transferee of Registrable Securities who agrees in writing, in form reasonably satisfactory to the Company, to be bound by all of the terms hereof. All of the obligations of the Company hereunder shall survive any such transfer. Except as provided in Section 8 , nothing expressed or referred to in this Agreement shall be construed to give any Person other than the parties to this Agreement (and their successors and assigns) any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement.

(e) Headings . The headings and subheadings in this Agreement are included for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

(f) Governing Law; Jurisdiction . This Agreement shall be construed, interpreted and the rights of the parties determined in accordance with the laws of the State of New York, as applied to agreements among New York residents entered into and wholly to be performed within the State of New York (without reference to any choice of law rules that would require the application of the laws of any other jurisdiction).

(i) Any claim, action, suit or proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby shall be heard and determined exclusively in any New

 

15


York state or federal court sitting in The City of New York, County of Manhattan, and each of the parties hereto hereby consents to the exclusive jurisdiction of such courts (and of the appropriate appellate courts therefrom in any such claim, action, suit or proceeding) and irrevocably waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of venue of any such claim, action, suit or proceeding in any such court or that any such claim, action, suit or proceeding that is brought in any such court has been brought in an inconvenient forum.

(ii) Subject to applicable law, process in any such claim, action, suit or proceeding may be served on any party anywhere in the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing and subject to applicable law, each party agrees that service of process on such party as provided in Section 10(c) shall be deemed effective service of process on such party. Nothing herein shall affect the right of any party to serve legal process in any other manner permitted by law or at equity. WITH RESPECT TO ANY SUCH CLAIM, ACTION, SUIT OR PROCEEDING IN ANY SUCH COURT, EACH OF THE PARTIES IRREVOCABLY WAIVES AND RELEASES TO THE OTHER ITS RIGHT TO A TRIAL BY JURY, AND AGREES THAT IT WILL NOT SEEK A TRIAL BY JURY IN ANY SUCH PROCEEDING.

(g) Severability . If any provision of this Agreement is deemed or held to be illegal, invalid or unenforceable, this Agreement shall be considered divisible and inoperative as to such provision to the extent it is deemed to be illegal, invalid or unenforceable, and in all other respects this Agreement shall remain in full force and effect; provided, however, that if any provision of this Agreement is deemed or held to be illegal, invalid or unenforceable the parties agree to replace such illegal, invalid or unenforceable provision with a provision that is legal, valid and enforceable that achieves the original intent of the parties as closely as possible. Further, should any provision contained in this Agreement ever be reformed or rewritten by any judicial body of competent jurisdiction, such provision as so reformed or rewritten shall be binding upon all parties hereto.

(h) Entire Agreement . This Agreement constitutes the entire agreement among the parties hereto pertaining to the subject matter hereof and supersedes all prior agreements and understandings pertaining thereto.

(i) Cumulative Remedies . The rights and remedies provided by this Agreement are cumulative and the use of any one right or remedy by any party shall not preclude or waive its right to use any or all other remedies. Said rights and remedies are given in addition to any other rights the parties may have by law, statute, ordinance or otherwise.

(j) No Strict Construction . The parties hereto have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement.

 

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(k) Termination Upon Change of Control . Notwithstanding anything to the contrary herein, this Agreement (excluding any then existing indemnification obligations) shall terminate upon a Change of Control.

(l) Counterparts . This Agreement may be executed by facsimile and in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

(m) Jury Trial . EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING (WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATED TO THIS AGREEMENT .

[ Signature page follows ]

 

17


IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.

 

CLOVIS ONCOLOGY, INC.
By:  

/s/ Patrick J. Mahaffy

Name:   Patrick J. Mahaffy
Title:   President and Chief Executive Officer

[Registration Rights Agreement]


Luxcapital V. S.a.r.l.
By:  

/s/ Antoine Papiernik

Name:   Antoine Papiernik
Title:   Managing Partner of Sofinnova Partners

Cooperatieve Aescap Venture I U.A. (cooperative association)

By:  

/s/ Domenico Valerio

Name:   Domenico Valerio
Title:   Authorized Signatory

Principia S.g.r. - Società di gestione del risparmio S.p.A.

By:  

/s/ Roberto Mazzei

Name:   Roberto Mazzei
Title:   Chairman

/s/ Silvano Spinelli

Name:   Silvano Spinelli

/s/ Maria Gabriella Camboni

Name:   Maria Gabriella Camboni

/s/ Ennio Cavalletti

Name:   Ennio Cavalletti

/s/ Huh Hoyoung

Name:   Huh Hoyoung

/s/ Jacques Theurillat

Name:   Jacques Theurillat

/s/ Roberta Cereda

Name:   Roberta Cereda

[Registration Rights Agreement]


EXHIBIT A

LuxCapital V S.à r.l.

Cooperatieve Aescap Venture I U.A.

Principia SGR S.p.A.

Silvano Spinelli

Maria Gabriella Camboni

Ennio Cavalletti

Jacques Theurillat

Roberta Cereda

Hoyoung Huh

Exhibit 10.1

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

Development and Commercialization Agreement

by and between

ADVENCHEN LABORATORIES LLC

And

ETHICAL ONCOLOGY SCIENCE S.P.A.

October 24, 2008


TABLE OF CONTENTS

Cont’d

TABLE OF CONTENTS

 

         P AGE  

ARTICLE 1 DEFINITIONS

     1   

ARTICLE 2 LICENSES AND EXCLUSIVITY

     11   

2.1

 

Licenses to EOS under Advenchen Technology

     11   

2.2

 

Expiration of Royalty Term

     11   

2.3

 

Non-Blocking Patent License to Advenchen

     11   

2.4

 

Non-Blocking Patent License to EOS

     11   

2.5

 

No Implied Licenses

     12   

2.6

 

Registration of License

     12   

2.7

 

No Inconsistent Grant of Rights

     12   

ARTICLE 3 DISCLOSURE OF KNOW-HOW AND TECHNOLOGY TRANSFER

     12   

3.1

 

Delivery of Information

     12   

3.2

 

Delivery of Materials

     12   

3.3

 

Additional Cooperation and Assistance

     13   

ARTICLE 4 DILIGENCE

     13   

4.1

 

Diligence

     13   

4.2

 

Reporting

     13   

ARTICLE 5 PRODUCT DEVELOPMENT AND REGULATORY MATTERS

     14   

5.1

 

Project Managers

     14   

5.2

 

Overview of Product Development

     14   

5.3

 

Cooperation and Costs For Regulatory Matters in the Licensed Territory

     14   

ARTICLE 6 COMMERCIALIZATION

     14   

6.1

 

Overview of Commercialization in the Licensed Territory

     14   

6.2

 

Pricing; Reimbursement

     15   

 

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ARTICLE 7 ADVENCHEN DEVELOPMENT OUTSIDE OF THE LICENSED TERRITORY

     15   

7.1

 

Advenchen Reserved Rights

     15   

7.2

 

Product Development Outside of the Licensed Territory

     15   

7.3

 

Adverse Event Reporting

     16   

7.4

 

Cross-Reference Rights

     16   

7.5

 

Compliance

     16   

7.6

 

Non-Competition

     16   

ARTICLE 8 COMPENSATION

     16   

8.1

 

Upfront Fee

     16   

8.2

 

Development Milestone Payments

     17   

8.3

 

Commercialization Milestone Payments

     18   

8.4

 

Royalties

     18   

8.5

 

Sublicense Revenue

     19   

8.6

 

EOS Option Upon Change of Control

     20   

8.7

 

No Projections

     20   

ARTICLE 9 PAYMENTS

     21   

9.1

 

Royalty Reports and Payment

     21   

9.2

 

Foreign Exchange

     21   

9.3

 

Payment Method; Late Payments

     21   

9.4

 

Records; Audits

     21   

9.5

 

Taxes

     22   

ARTICLE 10 INTELLECTUAL PROPERTY MATTERS

     23   

10.1

 

Prosecution of Patents

     23   

10.2

 

Patent Term Extensions in the Licensed Territory

     24   

 

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10.3

 

Infringement of Patents by Third Parties

     24   

10.4

 

Infringement of Third Party Rights in the Licensed Territory

     25   

10.5

 

Patent Marking

     25   

10.6

 

Patent Oppositions and Other Proceedings

     26   

10.7

 

Patent Validity Challenges

     26   

ARTICLE 11 REPRESENTATIONS AND WARRANTIES

     26   

11.1

 

Mutual Representations and Warranties

     26   

11.2

 

Additional Representations and Warranties of Advenchen

     27   

11.3

 

No Other Representations or Warranties

     29   

ARTICLE 12 INDEMNIFICATION

     29   

12.1

 

Indemnification by Advenchen

     29   

12.2

 

Indemnification by EOS

     29   

12.3

 

Indemnification Procedures

     30   

12.4

 

Limitations of Liability

     30   

12.5

 

Insurance

     31   

ARTICLE 13 CONFIDENTIALITY

     31   

13.1

 

Confidentiality

     31   

13.2

 

Authorized Disclosure

     31   

13.3

 

Publicity

     32   

13.4

 

Publications

     33   

ARTICLE 14 TERM AND TERMINATION

     33   

14.1

 

Term

     33   

14.2

 

Early Termination

     33   

14.3

 

Termination for Breach

     34   

14.4

 

Unilateral Termination by Advenchen for Failure to Develop

     34   

 

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14.5

 

Termination for Safety

     34   

14.6

 

Continuing Rights of Commercialization Sublicensees

     34   

14.7

 

Effect of Termination for EOS

     35   

14.8

 

Effect of Termination for Advenchen

     35   

14.9

 

Rights in Bankruptcy

     36   

14.10

 

Survival

     36   

ARTICLE 15 EXPANDED FIELD

     36   

15.1

 

Right of First Negotiation

     36   

15.2

 

Maintenance of Expanded Field Assets

     37   

15.3

 

No Third Party Collaboration

     37   

15.4

 

Competitive Sales

     37   

ARTICLE 16 DISPUTE RESOLUTION

     37   

16.1

 

Disputes

     37   

16.2

 

Early Resolution By the Parties

     38   

16.3

 

Injunctive Relief

     38   

16.4

 

Arbitration

     38   

ARTICLE 17 MISCELLANEOUS

     38   

17.1

 

Entire Agreement; Amendment

     38   

17.2

 

Force Majeure

     39   

17.3

 

Notices

     39   

17.4

 

No Strict Construction; Headings

     39   

17.5

 

Assignment

     40   

17.6

 

Performance by Affiliates

     40   

17.7

 

Further Actions

     40   

17.8

 

HSR Filing

     40   

 

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17.9

 

Severability

     41   

17.10

 

No Waiver

     41   

17.11

 

Independent Contractors

     41   

17.12

 

English Language; Governing Law

     41   

17.13

 

Counterparts

     41   

 

v


DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This D EVELOPMENT AND C OMMERCIALIZATION A GREEMENT (the “ Agreement ”) is entered into as of October 24, 2008 (the “ Effective Date ”) between A DVENCHEN L ABORATORIES LLC , a company organized under the laws of the State of California, U.S.A., with registered offices at 9135 Reseda Boulevard, Suite 238, Northridge, California, USA (“ Advenchen ”), and E THICAL O NCOLOGY S CIENCE S.P.A. , a company incorporated under the laws of Italy, with registered offices at Via Monte di Pietá, 1/A, 20121 Milan, Italy (“ EOS ”). Advenchen and EOS are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

W HEREAS , Advenchen is developing its proprietary small molecule protein tyrosine kinase inhibitor product AL3810, as further described herein, for the treatment of cancer;

W HEREAS , EOS possesses substantial resources and expertise in the development, marketing, and commercialization of biopharmaceutical products for the treatment of cancer in the Licensed Territory (as defined below);

W HEREAS , EOS desires to conduct further development of the Product (as defined below) in the Field (as defined below) through regulatory approval in the Licensed Territory, and to obtain commercialization rights to the Product in the Field in the Licensed Territory and Advenchen is willing to grant such rights on the terms and conditions hereof; and

W HEREAS , EOS also desires to have a right of first refusal to develop and commercialize the Product in the Expanded Field (as defined below) in the Licensed Territory, and Advenchen is also willing to grant such rights on the terms and conditions hereof.

N OW T HEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

1.1 Additional Patent Rights ” shall mean the patent rights to claims 9 and 10 of publications WO 2008/112407 and US2008/0227811 and the inventions contained and expressed in such claims with respect to the processes and intermediates of the Product as set forth therein, and as set forth in any corresponding claim of any Patent issuing from such publications or otherwise continuing therefrom (including any foreign equivalents).

1.2 Additional Product ” means any new formulation, dosage form, improvement, or mode of administration of the Compound.

1.3 Advenchen Indemnitees ” has the meaning set forth in Section 12.2.


1.4 Advenchen Know-How ” means all Know-How that is Controlled by Advenchen or its Affiliates as of the Effective Date or during the Term and is necessary or reasonably useful for the Development, Manufacturing or Commercialization of the Product in the Field or the Expanded Field (as applicable) in accordance with the terms of this Agreement. For clarity, Advenchen Know-How includes Know-How relating to previously conducted Non-Clinical Studies for the Product and Know-How related to the manufacturing process for the Product, including the Information identified in Exhibit A .

1.5 Advenchen Materials ” means the chemical compounds and biological materials that are Controlled by Advenchen or its Affiliates as of the Effective Date or during the Term and are necessary or reasonably useful for the Development, Manufacture or Commercialization of the Product in the Field or the Expanded Field (as applicable) in accordance with the terms of this Agreement, including the compounds and other materials identified in Exhibit B .

1.6 Advenchen Patent ” means any Patent that (a) is Controlled by Advenchen or its Affiliates as of the Effective Date or at any time during the Term, and (b) would, but for the license granted by Advenchen hereunder, be infringed by the Development, Manufacture, use, sale, offer for sale, having sold, Distribution, import, or any other Commercialization of the Product by or on behalf of EOS or its sublicensee(s) in the Field or the Expanded Field (as applicable). Advenchen Patents shall include without limitation (i) those Patents listed on Exhibit C , and (ii) any patent issuing from an application claiming priority thereto or otherwise continuing therefrom.

1.7 Advenchen Technology ” means the Advenchen Patents and Advenchen Know-How.

1.8 Affiliate ” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise. Advenchen represents that, as of the Effective Date, Advenchen Laboratories Nanjing Ltd. is not an “Affiliate” of Advenchen under the terms of this Section 1.8.

1.9 Best Knowledge ” means, as applied to a Party, that the applicable Party’s senior management with operational responsibility for the Development or Commercialization of the Product is actually aware of a particular fact or other matter following reasonably diligent inquiry of its management employees with primary responsibility for the applicable subject matter.

1.10 Change of Control ” means, as applied to a Party, an event where (a) any person or entity not an Affiliate of such Party acquires directly or indirectly the beneficial ownership of any voting security of a Party, or if the percentage ownership of such person or entity in the voting securities of a Party is increased through stock redemption, cancellation or other recapitalization, and immediately after such acquisition or increase such person or entity is,

 

2.


directly or indirectly, the beneficial owner of voting securities representing fifty percent (50%) or more of the total voting power of all of the then-outstanding voting securities of such Party; (b) there is the consummation of a merger, consolidation, recapitalization, or reorganization of such Party, other than any such transaction which would result in stockholders or equity holders of such Party or an Affiliate of such Party immediately prior to such transaction owning at least fifty percent (50%) of the outstanding securities of the surviving entity in such transaction immediately following such transaction; or (c) the stockholders or equity holders of a Party shall approve a plan of complete liquidation of the Party or an agreement for the sale or disposition by the Party of all or a substantial portion of the Party’s assets, other than to an Affiliate.

1.11 Claims ” has the meaning set forth in Section 12.1.

1.12 CMC ” means chemistry, manufacturing and controls as specified by the FDA or foreign equivalent.

1.13 Commercialization ,” with a correlative meaning for “ Commercialize ” and “ Commercializing ,” means all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, Detailing, medical education and medical liaison activities, publication, marketing, pricing, reimbursement, sale, and distribution of the Product, including: (a) strategic marketing, sales force detailing, advertising, medical education and liaison, and market and Product support; and (b) all customer support, Product distribution, invoicing and sales activities.

1.14 Commercialization Sublicensee ” means any Third Party to which EOS or its Affiliate sublicenses its rights under Section 2.1(a) for Commercialization of the Product by such Third Party in one or more of the countries in the Licensed Territory and that agrees to provide Sublicense Revenue to EOS or its Affiliate (or their designee).

1.15 Commercially Reasonable Efforts ” means, with respect to a Party’s obligation under this Agreement, efforts and resources normally used by a similarly situated company in the pharmaceutical industry for a product owned by or licensed to it, and activities related to the development and commercialization of such product, which is of similar commercial potential at a similar stage in its development or product lifecycle, taking into account various issues, such as its safety and efficacy, product profile, cost to develop, the time required to complete development, the competitiveness of the marketplace, the company’s patent position with respect to such product, the third-party patent landscape relevant to the product, the regulatory structure involved, the likelihood of regulatory approval, the anticipated or actual profitability of the applicable product, and all other relevant factors, all as measured by the facts and circumstances at the time such efforts are due.

1.16 Competing Product ” means ***.

1.17 Competitive Sales ” has the meaning set forth in Section 15.4.

1.18 Compound ” means a pharmaceutical composition, in any dosage form or form of administration, that contains Advenchen’s small molecule protein tyrosine kinase inhibitor designated as AL3810 and its pharmaceutically acceptable salts as described on Exhibit D .

 

3.


1.19 Confidential Information ” means, with respect to a Party, all non-public Information of such Party that is disclosed to the other Party under this Agreement, whether in oral, written, graphic, or electronic form. All non-public Information disclosed by either Party pursuant to the Confidentiality Disclosure Agreement between the Parties dated November 27, 2007, or the Term Sheet last signed on February 25, 2008, shall be deemed to be such Party’s Confidential Information disclosed hereunder.

1.20 Control ” means, with respect to any material, Know-How, or intellectual property right, that a Party or its Affiliates (as applicable) (a) owns or (b) has a license to such material, Know-how, or intellectual property right and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party.

1.21 Designated Executive ” means a senior executive of a Party designated in writing by such Party.

1.22 Detail ” means a face-to-face or electronic presentation and any associated in-service training regarding the features of the Product by a Party’s sales representative to one or several medical professional(s) having prescribing authority in the Field or the Expanded Field (as applicable), including pharmacists, as well as to other individuals or entities that have significant impact or influence on prescribing decisions in the Field or the Expanded Field (as applicable).

1.23 Develop ” or “ Development ” means all research and development activities relating to preparing and conducting and documenting Non-Clinical Studies, human clinical studies, CMC development and regulatory activities ( e.g. , regulatory applications) with respect to the Product.

1.24 Development Documentation ” means all Development Information for the Product, including any documentation having test data for the Product (including pharmacological, biological, chemical, biochemical, clinical study data and data resulting from Non-Clinical Studies), Regulatory Materials, CMC information, stability data, and other manufacturing or study data for the Product.

1.25 Distribution ,” with a correlative meaning for “ Distribute ” and “ Distributing ,” means the materials, packaging activities, processes, procedures specifically designed and necessary for warehousing, transferring and handling Product from any applicable manufacturing facility, up to and including the physicians’ office,

1.26 Dollar ” means a U.S. dollar, and “ $ ” shall be interpreted accordingly.

1.27 Effective Date ” has the meaning set forth in the first paragraph of this Agreement.

1.28 EMEA ” means the European Medicine Evaluation Agency, or any successor entity thereto.

 

4.


1.29 EOS Improvements ” means any improvement, modification, derivative, analogue, mutation, alteration, enhancement, new version, translation, adaptation or addition, in or to the Advenchen Technology made by or for EOS under this Agreement, or any part or aspect thereof.

1.30 EOS Indemnitees ” has the meaning set forth in Section 12.1.

1.31 EOS Know-How ” means all Know-How (a) to the extent related to the Product in the Field that arises from EOS’s activities under this Agreement and is necessary for the Development, Manufacture or Commercialization of such Products in the Field, or (b) that EOS Controls during the Term that EOS incorporates in Products and that is necessary for the Development, Manufacture or Commercialization of such Products in the Field. For clarity, EOS Know-How in each case (a) and (b) excludes any Know-How that is not specific to such Products in the Field but generally applicable to EOS’s activities outside of this Agreement.

1.32 EOS Patent ” means any Patent Controlled by EOS during the Term that EOS employs in the Development, Manufacture or Commercialization of Products in the Field and is necessary for such Development, Manufacture of Commercialization, as well as any patent issuing from an application claiming priority thereto or otherwise continuing therefrom.

1.33 EOS Technology ” means the EOS Patents and EOS Know-How.

1.34 Expanded Field ” means any and all human or animal therapeutic (including prevention and treatment) or diagnostic applications other than those in the Field.

1.35 Expanded Field Assets ” means the Advenchen Technology in the Expanded Field.

1.36 Extraterritorial Studies ” means all Non-Clinical Studies and clinical studies conducted in the People’s Republic of China (PRC) by or for Advenchen, whether conducted prior to or following Regulatory Approval of the Product, including: Phase 1, 2, 3 or 4 Clinical Studies or pivotal studies (including studies for additional indications or label expansion); investigator-sponsored trials, safety or surveillance studies; pharmacoeconomic studies; pharmacoepidemiology studies; reimbursement studies; and other studies.

1.37 FD&C Act ” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.

1.38 FDA ” means the U.S. Food and Drug Administration or any successor entity thereto.

1.39 Field ” means oncology (including the prevention, diagnosis, and treatment of tumors), and hemathological malignancies, myelodisplasia and myeloproliferative disorders and the prevention, diagnosis, and treatment of the same.

1.40 First Commercial Sale ” means the first sale to a Third Party of a Product in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction.

 

5.


1.41 Good Manufacturing Practices ,” “ cGMP or GMP ” means the then-current good manufacturing practices as required by the Regulatory Authority in the Licensed Territory for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions in the Licensed Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH and other applicable regulations.

1.42 Governmental Authority ” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.43 IND ” means (a) an Investigational New Drug application as defined in the FD&C Act and applicable regulations promulgated hereunder by the FDA, or (b) the equivalent application to the equivalent Governmental Authority in any other regulatory jurisdiction outside the U.S., the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.44 Indemnified Party ” has the meaning set forth in Section 12.3.

1.45 Indemnifying Party ” has the meaning set forth in Section 12.3.

1.46 Information ” means any data, results, technology, business and financial information and information of any type whatsoever, in any tangible or intangible form, including, without limitation, specifications, software, marketing reports, test data (including pharmacological, biological, chemical, biochemical, clinical study data and data resulting from Non-Clinical Studies), CMC information, stability data, and other study data.

1.47 Initiation ” of a clinical trial shall mean the dosing of the first patient in such trial.

1.48 Know-How ” means all technical Information and know-how, including inventions, discoveries, trade secrets, instructions, processes, formulae, materials, expertise and other technology applicable to formulations, compositions, products or their Manufacture, Development, registration, use or Commercialization or methods of assaying or testing them or processes for their manufacture, formulations containing them, compositions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, Regulatory Materials and copies thereof, relevant to the Development, Manufacture, use or Commercialization of and/or which may be useful in studying, testing, Development, production or formulation of products, or intermediates for the synthesis thereof.

1.49 Laws ” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

 

6.


1.50 Licensed Territory ” means worldwide excluding the People’s Republic of China.

1.51 Manufacture ” with a correlative meaning for “ Manufacturing ,” means all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including manufacturing Product in finished form for Development, manufacturing finished Product for Commercialization, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, all stability studies including those for registration, the development and validation of testing methods used for, but not limited to, release test, stability test and every testing method for commercial use, preparation of the documents of any “Manufacture” related reports in “common technical document” form described in International Conference of Harmonization of Technical Requirements of Registration of Pharmaceuticals for Human Use (ICH), and documents necessary for clinical and market authorization development including but not limited to development history reports for drug substance and drug product, comparability studies and reports, in the Licensed Territory and regulatory activities related to any of the foregoing.

1.52 Marketing Authorization Application ” or “ MAA ” means an application to the appropriate Regulatory Authority for approval to market the Product (but excluding pricing approval) in any particular jurisdiction.

1.53 MHLW ” means the Ministry of Health, Labor and Welfare of Japan, or any successor entity.

1.54 Net Sales ” means, with respect to a particular time period, the total amounts invoiced by EOS, its Affiliates and their respective sublicensees for sales of Products made during such time period to unaffiliated Third Parties, less the following deductions in each case to the extent reasonable and customary and actually allowed or incurred with respect to such sales:

(a) discounts, including cash and quantity discounts (including early payment discounts), charge-back payments, and rebates actually granted or administrative fees actually paid to: trade customers; patients (including those in the form of a coupon or voucher); managed health care entities; drug benefit managers; group purchasing organizations; federal, state, or local government (including those for governmental, regulatory or agency mandated rebate programs); the agencies, purchasers and reimbursers of managed health care entities; and drug benefit managers;

(b) credits or allowances actually granted upon prompt payment or claims, damaged goods, rejections or returns of such Product, including in connection with recalls;

(c) freight, postage, shipping, transportation and insurance charges, in each case actually allowed or paid for delivery of Product, to the extent billed or recognized;

(d) taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of such Product, including, without limitation, value-added and sales taxes;

 

7.


(e) amounts actually paid to Third Party distributors solely in respect of the sale of Product;

(f) the actual amount of any write-offs for bad debt; provided that an amount subsequently recovered and identified with the invoice for which the amount had been written off will be thereafter treated as Net Sales. EOS will use Commercially Reasonable Efforts to minimize bad debts; and

(g) any other specifically identifiable amounts included in gross amounts invoiced for Products, to the extent such amounts are customary exclusions from net sales calculations in the pharmaceutical or biotechnology industries in the applicable country or countries in the Licensed Territory for reasons substantially equivalent to those listed above and are reasonable in amount relative to similar deductions taken by EOS or its applicable sublicensee in calculating net sales of their other products.

Notwithstanding the foregoing, amounts invoiced by EOS, its Affiliates, or their sublicensees for the sale of Product among EOS, its Affiliates or their respective sublicensees for resale shall not be included in the computation of Net Sales hereunder and such amounts shall be accounted for only once. For purposes of determining Net Sales, a “sale” shall not include reasonable transfers or dispositions, at no cost, as samples or for charitable purposes, or transfers or dispositions at no cost for Non-Clinical Studies, clinical or regulatory purposes. Net Sales shall be accounted for in accordance with standard EOS practices for operation by EOS, its Affiliates or sublicensees, as practiced in the relevant country in the Licensed Territory, but in any event in accordance with generally accepted accounting principles, consistently applied in such country in the Licensed Territory. Product sales are recognized when persuasive evidence of an arrangement with a Third Party at a fixed or determinable price exists, title and risk of loss has passed to the Third Party (generally upon receipt by the Third Party, and collectability of amounts billed is reasonably assured). Provisions for discounts, rebates, chargebacks, and estimated returns shall be recorded at the time of sale.

In the event the Product is sold in a finished dosage form containing the Compound or an Additional Product in combination with one or more other active ingredients (a “ Combination Product ”), the Net Sales of the Product, for the purposes of this Agreement, shall be determined by multiplying the Net Sales (as defined above) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. In the event that such average sale price cannot be determined for both the Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be agreed by the Parties based on the relative value contributed by each component, such agreement shall not be unreasonably withheld.

1.55 Non-Clinical Studies ” means in vivo animal or in vitro pharmacology, pharmacokinetic, or toxicology testing.

1.56 Patents ” means (a) pending patent applications (and patents issuing therefrom), issued patents, utility models and designs; and (b) reissues, substitutions, confirmations,

 

8.


registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any patents, patent applications, utility models or designs, in each case being enforceable within the applicable territory.

1.57 Phase 1 Clinical Trial ” means a clinical trial of a pharmaceutical product on healthy subjects or patients with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product.

1.58 Phase 2 Clinical Trial ” means a clinical trial of a pharmaceutical product on patients, including possibly pharmacokinetic studies, the principal purposes of which are to make a preliminary determination that such product is safe for its intended use and to obtain sufficient information about such product’s efficacy to permit the design of Phase 3 Clinical Trial.

1.59 Phase 3 Clinical Trial ” means a clinical trial on sufficient numbers of patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support approval of an application to a Regulatory Authority for the commercial marketing of such drug.

1.60 Phase 4 Clinical Trial ” means a clinical trial of a pharmaceutical product conducted after Regulatory Approval of the product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of such product ( e.g. , for expansion of product labeling or dose optimization), or (b) conducted as a condition for sale or post-approval commitment to or requirement of a Regulatory Authority. For clarity, a human clinical trial conducted to support a new Regulatory Approval for a new indication of a product shall not be considered a Phase 4 Clinical Trial.

1.61 Product ” means (a) the Compound or (b) any Additional Product, whether administered as a single pharmaceutical product or co-administered together with one or more other biologic or pharmaceutically active products or agents.

1.62 Product Infringement ” has the meaning set forth in Section 10.3(b).

1.63 Regulatory Approval ” means all approvals necessary, including price approval, for the commercial sale of the Product for the Field or Expanded Field (as applicable) in a given country or regulatory jurisdiction.

1.64 Regulatory Authority ” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.

1.65 Regulatory Exclusivity ” means any exclusive marketing rights or data exclusivity rights conferred by any Governmental Authority with respect to the Product, in a country under the jurisdiction of such Government Agency in the Licensed Territory, other than a patent right, including, without limitation, rights conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997, or rights similar thereto outside the U.S.

 

9.


1.66 Regulatory Materials ” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Governmental Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize the Product in a particular country, territory or possession. Regulatory Materials include, without limitation, INDs and MAAs.

1.67 ROFN Notice ” has the meaning set forth in Section 15.1.

1.68 ROFN Period ” has the meaning set forth in Section 15.1.

1.69 Royalty Term ” means, with respect to a particular Product within a particular country in the Licensed Territory, the period of time beginning upon the First Commercial Sale of the Product in the country until the date of expiration of the last Valid Claim in such country that would be infringed by the sale of such Product in such country. Thereafter, no further royalties shall be due with respect to such Product in such country.

1.70 Sublicense Revenue ” means all cash payments, the fair market cash value of any equity consideration (less base amounts paid for such equity consideration), and forgivable loans (to the extent actually forgiven) received by or due to EOS or its Affiliates from a Third Party in consideration for the grant of a sublicense under the Advenchen Technology, including any upfront payments, license maintenance fees, milestone payments or the like, less any milestone payments previously made to Advenchen under Section 8.2 or 8.3. For avoidance of doubt, “Sublicense Revenue” will not include: (a) running royalties (including any amounts paid based upon sales of a Product); and (b) any payment received from a sublicensee that shall be paid back to said sublicensee by EOS in the future. It is also understood that “Sublicense Revenue” shall not include amounts received in connection with a merger, consolidation or sale of substantially all of the business or assets of EOS.

1.71 Taxes ” means taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of Products, including, without limitation, consumption taxes.

1.72 Term ” means the term of this Agreement, as determined in accordance with Article 14.

1.73 Third Party ” means any entity other than Advenchen or EOS or an Affiliate of either of them.

1.74 Third Party Collaboration ” means a license, purchase, research, collaboration, co-promotion, co-Development, co-marketing, co-Detailing or any similar arrangement with a Third Party.

1.75 Third Party Royalties ” has the meaning set forth in Section 8.4(b).

1.76 Valid Claim ” means (a) an issued claim of an issued Patent within the Advenchen Patents which has not been (i) held unpatentable, invalid or unenforceable by a court or other government agency of competent jurisdiction in a decision from which no appeal can or

 

10.


has been taken; and (ii) admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; or (b) a pending claim of a pending Patent application within the Advenchen Patents which is being actively prosecuted in accordance with this Agreement and which has not been cancelled, abandoned or withdrawn from consideration, or finally determined to be unallowable by the applicable government agency of competent jurisdiction which no appeal can or has been taken. With respect to a Valid Claim of a pending patent application, the phrase to “infringe a Valid Claim” means to engage in an activity that would infringe (i.e., by either directly infringing, contributorily infringing, or inducing infringement of) such Valid Claim if it were contained in an issued patent.

ARTICLE 2

LICENSES AND EXCLUSIVITY

2.1 Licenses to EOS under Advenchen Technology .

(a) License Grant . Subject to the terms and conditions of this Agreement, Advenchen hereby grants, and shall cause each of its Affiliates to grant, EOS and its Affiliates an exclusive (even as to Advenchen and its Affiliates), royalty-bearing license, with the right to sublicense as provided below, under the Advenchen Technology, to Develop, Manufacture, use, make, have made, sell, offer for sale, have sold, Distribute, import and otherwise Commercialize the Product in the Field in the Licensed Territory.

(b) Sublicense Rights . EOS shall have the right to sublicense any of the rights set forth in Sections 2.1(a) and 2.4. Promptly after the execution of any sublicense agreement, EOS shall provide Advenchen with a copy of such agreement within thirty (30) days after execution of the agreement for the purpose of identifying the sublicensed territory, the sublicensee, the scope of rights and intellectual property rights granted and any relevant financial terms; provided, that any other information EOS reasonably deems to be confidential may be redacted. For clarity, any copies of such agreements provided by EOS hereunder shall be deemed and treated as EOS Confidential Information. EOS hereby covenants that it will include in all agreements granting sublicenses under the rights granted in Section 2.1(a) provisions consistent with the terms of this Agreement as applicable to a sublicensee.

2.2 Expiration of Royalty Term . With respect to each Product, on a country-by-country basis, upon the expiration of the Royalty Term applicable to such Product in a specific country, the rights and licenses granted to EOS under Section 2.1 shall become fully paid up, royalty-free, perpetual and irrevocable with regards to such Product in such country.

2.3 Non-Blocking Patent License to Advenchen . Subject to the terms and conditions of this Agreement, EOS hereby grants to Advenchen, under the EOS Patents owned by EOS, a personal, non-transferable (except pursuant to Section 17.5), non-exclusive, royalty-free license to use, make, and have made EOS Improvements in the Field solely for the purposes of Development of the Product outside of the Licensed Territory.

2.4 Non-Blocking Patent License to EOS . Subject to the terms and conditions of this Agreement, Advenchen hereby grants, and shall cause its Affiliates to grant, EOS and its

 

11.


Affiliates a non-exclusive, royalty-free license, with the right to sublicense as provided in Section 2.1(b), under the Additional Patent Rights for the purpose of exercising the rights under Section 2.1.

2.5 No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party grants any license, express or implied, under its intellectual property rights to the other Party.

2.6 Registration of License . Notwithstanding anything to the contrary in Article 13, EOS, at its expense, may register the licenses granted under this Agreement in any country of the Licensed Territory. Upon request by EOS, Advenchen agrees promptly to, and to cause each of its Affiliates to, execute any “short form” licenses consistent with the terms and conditions of this Agreement submitted to it by EOS reasonably necessary to effect the foregoing registration in such country.

2.7 No Inconsistent Grant of Rights . Advenchen agrees not to, and shall cause each of its Affiliates not to, grant any Third Party any rights inconsistent with the rights and licenses granted to EOS under this Agreement.

 

ARTICLE 3

DISCLOSURE OF KNOW-HOW AND TECHNOLOGY TRANSFER

3.1 Delivery of Information .

(a) Initial Delivery . Within thirty (30) days after the Effective Date, Advenchen shall deliver to EOS all of the items of Advenchen Know-How identified in Exhibit A-1 (including, in English, copies of all identified Development Documentation). Within sixty (60) days after the Effective Date, Advenchen shall deliver to EOS all of the items of Advenchen Know-How identified in Exhibit A-2 (including, in English, copies of all identified Development Documentation).

(b) Additional Disclosures of Information . In addition to the initial delivery of Advenchen Know-How set forth in Section 3.1(a), beginning on the Effective Date and thereafter on a continuing basis during the Term, Advenchen, without additional consideration, shall disclose to EOS all Advenchen Know-How that is not specifically identified in Exhibit A and previously delivered to EOS hereunder. Such disclosure shall include all Advenchen available Know-How pertaining to the Manufacture and Development of the Compound and/or Product, including manufacturing batch records, Development reports, analytical results, raw material and excipient sourcing information, quality audit findings and any other relevant technical information.

3.2 Delivery of Materials .

(a) Initial Delivery . Within thirty (30) days after the Effective Date, Advenchen shall also deliver to EOS all items of Advenchen Materials identified in Exhibit B (if any). Within thirty (30) days of receipt of the Advenchen Materials, Advenchen shall invoice EOS, and EOS shall pay Advenchen, a reimbursement payment for the Advenchen Materials delivered to EOS equal to Advenchen’s direct costs attributable to the purchase or production of such Advenchen Materials.

 

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(b) Limited Warranty . Advenchen warrants that any Product delivered by Advenchen to EOS hereunder will at the time of delivery be manufactured, tested and delivered in accordance with any Laws applicable to the manufacture, use and delivery of such Product for Development. Any lot of Product delivered by Advenchen which does not conform to the warranty provided in this Section and is found to be non-conforming (as confirmed by the analysis of a neutral third-party laboratory agreed upon by both Parties) within ninety (90) days of delivery will be replaced by Advenchen at no further charge, or, at EOS’s option, the cost thereof shall be repaid to EOS.

3.3 Additional Cooperation and Assistance . Advenchen will provide reasonable assistance to EOS or its designee in connection with understanding and using the Advenchen Technology for purposes consistent with this Agreement and the licenses and rights granted to EOS hereunder, including by providing information to assist EOS or its designee in developing formulations of the Product and its related activities. Without limiting the generality of the foregoing, Advenchen agrees to make its personnel and the personnel of its Affiliates reasonably available to answer questions regarding the Advenchen Technology (including Know-How relating to Manufacturing of the Product).

ARTICLE 4

DILIGENCE

4.1 Diligence . EOS shall use Commercially Reasonable Efforts to develop and commercialize at least one Product, directly or through its Affiliates, sublicensees and/or contractors; provided however, EOS will not be required to Commercialize the Product in every country in the Licensed Territory. Notwithstanding the foregoing sentence, EOS’s obligation to use such efforts shall not apply to the extent of any delay or failure by or on behalf of Advenchen (including Advenchen’s failure to supply Products in accordance with the terms of this Agreement or to timely transfer Advenchen Know-How or materials to EOS or its designee).

4.2 Reporting . EOS agrees to keep Advenchen reasonably informed as to its Development and Commercialization activities with respect to Products. Without limiting the foregoing, EOS shall provide Advenchen with written reports no less frequently than annually during the Term (commencing with the first anniversary of the Effective Date) summarizing EOS’s efforts to Develop and Commercialize Products hereunder. All reports, updates, and other information provided by EOS to Advenchen under this Agreement (including under this Section 4.2), shall be considered Confidential Information of EOS, subject to the terms of Article 13 hereof.

 

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ARTICLE 5

PRODUCT DEVELOPMENT AND REGULATORY MATTERS

5.1 Project Managers . Promptly following the Effective Date, each Party shall designate in writing an individual to facilitate communication and coordination of the Parties’ activities under this Agreement relating to Products.

5.2 Overview of Product Development . The Parties desire and intend to collaborate with respect to the Development of the Product in the Licensed Territory in the Field, as and to the extent set forth in this Agreement. For clarity, Advenchen acknowledges that EOS may contract with one or more Third Parties (including, but not limited to contract manufactures and Commercialization Sublicensees) to engage in any such Development efforts. The Development of the Product in the Field for the Licensed Territory shall be conducted in a manner consistent with the following principles: (a) seeking Regulatory Approval that includes the appropriate label for such Product in light of the clinical data, and (b) obtaining Regulatory Approval for such Product consistent with the preceding clause and in a timely manner.

5.3 Cooperation and Costs For Regulatory Matters in the Licensed Territory . Advenchen shall assist EOS, as EOS may reasonably request, in connection with the preparation and filing of all Regulatory Materials in the Licensed Territory as contemplated under this Agreement. Any costs and expenses incurred by Advenchen related to its assistance hereunder (including the preparation, maintenance, formatting and filing of the Regulatory Materials in the Field in the Licensed Territory) shall be borne solely by EOS.

ARTICLE 6

COMMERCIALIZATION

6.1 Overview of Commercialization in the Licensed Territory . As between the Parties, EOS will control all aspects of the Commercialization of the Product in the Field in the Licensed Territory, including, without limitation: (a) developing and executing a commercial launch and pre-launch plan; (b) marketing and promotion; (c) booking sales and distribution and performance of related services; (d) handling all aspects of order processing, invoicing and collection, inventory and receivables; (e) publications; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures in all material respects to the applicable Laws relating to the marketing, detailing and promotion of the Products in the Field in the countries of the Licensed Territory. For clarity, Advenchen acknowledges that EOS may contract with one or more Third Parties (including, but not limited to contract manufactures and Commercialization Sublicensees) to engage in any of the foregoing aspects. Except as otherwise provided in this Agreement, as between the Parties, EOS shall bear all of the costs and expenses incurred in connection with all such Commercialization activities.

 

14.


6.2 Pricing; Reimbursement .

(a) As between the Parties, EOS shall have the sole right to determine all pricing of the Product in the Licensed Territory. Notwithstanding anything in this Agreement express or implied to the contrary, Advenchen shall not have any right to direct, control, or approve SOS’s pricing of Products for the Licensed Territory. The provision to Advenchen of any pricing data in connection with the Commercialization Plan is for informational purposes only.

(b) As between the Parties, EOS shall have the sole right to determine the reimbursement strategy for the Product.

ARTICLE 7

ADVENCHEN DEVELOPMENT OUTSIDE OF THE LICENSED TERRITORY

7.1 Advenchen Reserved Rights . Subject to Section 7.6, notwithstanding the rights granted to EOS in Section 2.1, Advenchen reserves the rights under the Advenchen Technology to Develop, Manufacture, use, make, have made, sell, offer for sale, have sold, Distribute and otherwise Commercialize the Product solely outside of the Licensed Territory; provided however, Advenchen expressly covenants that it shall not exercise such rights in circumstances in which Advenchen knows or reasonably should know such Products will be distributed or sold inside the Licensed Territory. Advenchen represents and warrants that ***, as of the Effective Date, does not have ownership of or any rights to any intellectual property (including Patents) in the Licensed Territory relating to the Advenchen Technology that would otherwise be licensed to EOS and its Affiliates under this Agreement if it were Controlled by Advenchen. For each Third Party (including ***) receiving rights to Advenchen Technology outside of the Licensed Territory, Advenchen shall enter into valid written agreements with the Third Party requiring the Third Party to grant to Advenchen rights to intellectual property in the Licensed Territory that cover improvements to the Advenchen Technology made by or for such Third Party. Such agreements shall include terms sufficient to allow Advenchen to Control such intellectual property rights. In the event that Advenchen becomes aware of any such intellectual property rights, it shall promptly notify EOS. Advenchen shall take all steps necessary to fulfill and carry out the intent of the foregoing; provided however, that if Advenchen is unable to procure such rights after diligent efforts, Advenchen agrees to provide the right and opportunity for EOS to negotiate directly with such Third Party for such rights.

7.2 Product Development Outside of the Licensed Territory . As between the Parties, Advenchen shall be solely responsible and liable for any Development and/or Commercialization of the Product outside of the Licensed Territory. Without limiting the foregoing, as between the Parties, Advenchen shall be solely responsible, at its sole expense, for conducting any and all Extraterritorial Studies and for complying with any Laws applicable to any Extraterritorial Studies (including any Laws governing export or import of technical information or materials). Advenchen will communicate with EOS to provide certain updates regarding these Extraterritorial Studies. Additionally, prior to its submission or filing, Advenchen shall deliver to EOS in draft form a copy of any material Regulatory Materials to be filled by or for Advenchen with respect to the Product outside of the Licensed Territory. EOS will have the opportunity to review and provide comments thereon and Advenchen will reasonably take into account EOS’s comments.

 

15.


7.3 Adverse Event Reporting . Advenchen shall enter into valid written agreements with each Advenchen Affiliate or Third Party conducting Extraterritorial Studies which shall impose obligations on such Affiliate or Third Parties sufficient to allow Advenchen to meet its obligations under the following terms of Sections 7.3(a)-(c). Advenchen shall:

(a) provide to EOS in advance of initial or periodic submission to a Regulatory Authority (to the extent permissible under time constraints and reporting requirements) any and all adverse event reports from its Extraterritorial Studies in Advenchen’s possession or control;

(b) provide such adverse event reports in Advenchen’s possession or control to EOS contemporaneously with the provision of such reports to the applicable Regulatory Authority; and

(c) adhere to all requirements of applicable Laws that relate to the reporting and investigation of adverse events and keep EOS informed of such events.

7.4 Cross-Reference Rights . To the extent allowed under applicable Law, Advenchen shall grant or cause to be granted to EOS and its Affiliates or sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Advenchen or its Affiliates with any Regulatory Authority in the Excluded Territory with respect to the Product without any additional consideration. However, such master files shall not be used for any regulatory filing or other similar use without Advenchen’s prior written approval (which shall not be unreasonably withheld or delayed).

7.5 Compliance . Advenchen agrees that it shall, and cause its Affiliates to, conduct its Extraterritorial Studies (a) in compliance with all applicable regulatory standards outside of the Licensed Territory; and (b) without employing or using any person that has been debarred under Section 306(a) or 306(b) of the FD&C Act.

7.6 Non-Competition . Advenchen shall not, anywhere in the Licensed Territory, market, promote, advertise, sell or offer to sell, or otherwise Commercialize (or license or collaborate with a Third Party to do any of the foregoing) a Competing Product. For the avoidance of doubt, for purposes of this Section 7.6, any act or activity undertaken, or failure to act, by an Affiliate of Advenchen, which, if committed by Advenchen would constitute a breach of this Section 7.6, shall constitute a breach by Advenchen.

ARTICLE 8

COMPENSATION

8.1 Upfront Fee . In partial consideration for the prior cost of developing the Product and EOS’s rights in and to the Advenchen Technology licensed hereunder, EOS shall pay to Advenchen a one-time up-front fee of $***, to be payable as follows: $*** of such fee shall be due within *** (***) days after the Effective Date, and the remaining $*** shall be due within *** (***) days after the Effective Date.

 

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8.2 Development Milestone Payments .

(a) Payment Terms . EOS or its applicable sublicensees shall make milestone payments to Advenchen based on achievement of certain milestone events for the Product as set forth in this Section 8.2, in partial consideration for the prior cost of developing the Product. EOS or its applicable sublicensees shall pay to Advenchen the amounts set forth below within thirty (30) days after receipt of Advenchen’s invoice following the achievement of the corresponding milestone event; provided however, that with respect to the payments due under Sections (v), (vii) and (viii) below, EOS or its applicable sublicensee shall not be obligated to make the payment until the procedure set forth in Section 8.2(b) is completed. Each milestone payment by EOS or its applicable sublicensees to Advenchen hereunder shall be payable only once, regardless of the number of times achieved by the Products, and shall not be cumulative. Within fourteen (14) days of the occurrence of each milestone event, EOS or its applicable sublicensee shall provide written notice thereof to Advenchen.

 

Milestone Event

  

Milestone Payment

(i)

 

Upon ***.

   $*** USD

(ii)

 

Upon ***. For purposes of this milestone event,***.

   $*** USD

(iii)

 

Upon ***.

   $*** USD

(iv)

 

Upon ***.

   $*** USD

(v)

 

Upon ***.

   $*** USD (subject to Section 82(b))

(vi)

 

Upon ***.

   $*** USD

(vii)

 

Upon ***.

   $*** USD (subject to Section 8.2(b))

(viii)

 

Upon ***.

   $*** USD (subject to Section 8.2(b))

(b) Adjustments to Approval Milestones . For each applicable Approval under Section 8.2(a)(v), (a)(vii) or (a)(viii), within thirty (30) days from the applicable approval, EOS shall provide an estimated projection, made in good faith, of the first year of Net Sales for the Product subject to the Approval. For purposes of this Section 8.2(b), “ approval ” means, with respect to the registration dossier submitted for the first indication for the Product, the receipt of: the “letter of acceptance for review” by the FDA, of the “review calendar” by the EMEA, or the “approval letter” by the MHLW. If Advenchen disputes, in good faith, the accuracy of the projected Net Sales submitted by EOS, the Parties agree to engage a reputable

 

17.


Third Party consultant to conduct a standard projection analysis to determine the estimated first year of Net Sales. If the final estimate for the applicable Product is lower than $***, then the applicable milestone payment shall be adjusted as follows: if the milestone under Section 8.2(a)(v) is applicable, then milestone shall be adjusted from $*** to $***; if the milestone under Section 8.2(a)(vii) is applicable, the milestone shall be adjusted from $*** to $***; and if the milestone under Section 8.2(a)(viii) is applicable, the milestone shall be adjusted from $*** to $***. In the event that any milestone is adjusted, the applicable amounts removed from the milestone payment obligations under Section 8.2(a) shall be moved to Section 8.3 in the following manner: (a) the first $*** subject to an adjustment will be transferred to Section 8.3(a), the next $*** subject to an adjustment will be transferred to Section 8.3(b); and the last $*** subject to an adjustment will be transferred to Section 8.3(c). Each transferred amount will be subject to a transfer fee of ***% per annum until fully paid under the applicable milestone payment under Section 8.3; provided that the total transfer fee shall not exceed an amount equal to ***% of the transferred amount.

8.3 Commercialization Milestone Payments . EOS or its applicable sublicensees shall make the following one-time, milestone payments to Advenchen. Each milestone payment by EOS or its applicable sublicensees to Advenchen hereunder shall be payable only once, regardless of the number of times achieved by the Products, and shall not be cumulative. EOS or its applicable sublicensees shall pay to Advenchen the amount of such payment within thirty (30) days after receipt by EOS of Advenchen’s invoice following the achievement of each of the following performance events.

 

Milestone Event

  

Milestone Payment

(a) Upon *** of $***,

   $*** USD

(b) Upon *** of $***

   $*** USD

(c) Upon *** of $***

   $*** USD

8.4 Royalties .

(a) Royalty Rates for Licensed Territory . Subject to Section 8.4(b) below, and during the applicable Royalty Term, EOS shall pay to Advenchen a running royalty at the following incremental royalty rates, on aggregate, annual Net Sales of the Products in the Licensed Territory.

 

Net Sales in the Licensed Territory    Royalty Rate

For that portion of annual Net Sales less than or equal to $***

   ***%

For that portion of annual Net Sales greater than $*** but less than or equal to $***

   ***%

For that portion of annual Net Sales greater than $***

   ***%

 

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(b) Third Party Royalties . During the Term, if EOS determines, in good faith, that it is necessary to seek or exercise any license from any Third Party for intellectual property that is necessary or useful for the Development, Manufacture, storage, handling, use, promotion, sale, offer for sale, or importation of Products for sale in the Licensed Territory, EOS may credit up to *** percent (***%) of the amount of any royalties or other payments actually paid by EOS for such Third Party intellectual property (“ Third Party Royalties ”) against royalties payable to Advenchen under Section 8.4(a). EOS shall promptly notify Advenchen of such determination if it seeks to apply the credit. EOS may take such credit during any calendar quarter for which royalties are payable hereunder; provided, that in no event will such credit reduce the royalties payable to Advenchen for such calendar quarter by more than fifty percent (50%). Any share of such Third Party Royalties that remains uncredited due to the application of such floor maybe carried forward to subsequent calendar quarters.

8.5 Sublicense Revenue .

(a) Payment Rates . Subject to the terms of Section 8.5(b), in the event that EOS grants a sublicense to a Third Party under Section 2.1(b), EOS shall pay Advenchen a portion of any Sublicense Revenues received by EOS as set forth below:

(i) In the event that the applicable sublicense is executed on or before the date of initiation of Phase 1 Clinical Trial for the Product in the Field in the U.S., EOS shall pay Advenchen *** percent (***%) of the Sublicense Revenue received from the applicable sublicensee; or

(ii) In the event that the applicable sublicense is executed on or before the date of completion of the first Phase 2 Clinical Trial for the Product in the Field in the U.S., EOS shall pay Advenchen *** percent (***%) of the Sublicense Revenue received from the applicable sublicensee; or

(iii) In the event that the applicable sublicense is executed after the date of completion of the first Phase 2 Clinical Trial for the Product in the Field in the U.S., EOS shall pay Advenchen *** percent (***%) of the Sublicense Revenue received from the applicable sublicensee.

(iv) Subject to the terms of Section 9.1, for the avoidance of doubt, all payments to Advenchen under this Section 8.5(a) (if any) shall only become due and payable upon EOS’s actual receipt of the Sublicense Revenue from the applicable sublicensee.

(b) Removal of Milestone Payments Or Sublicense Revenue Payments . Notwithstanding the provisions of Sections 8.2, 8.3 and 8.5(a), upon the execution date of an agreement between EOS and a Commercialization Sublicensee, at the option of Advenchen, the amount applicable under Section 8.5(a) above (when it is greater than Section 8.2 or 8.3 of this Agreement) shall entirely replace all the milestone payments to be made by EOS to Advenchen per Sections 8.2 and 8.3 which have not yet become due at the date of signatures of the agreement between EOS and said sublicense and EOS shall only be required to pay to Advenchen the applicable percentage of the Sublicense Revenue in accordance with

 

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Section 8.5(a). Accordingly, upon such election of Advenchen, (i) EOS shall have no obligation to provide any additional payments to Advenchen under Section 8.2 or 8.3 of this Agreement and all of the terms under Sections 8.2 and 8.3 shall have no further force or effect, and (ii) Advenchen, on its behalf and on behalf of each of its Affiliates, will expressly waive any and all rights to receive any milestone that may become due under Sections 8.2 and 8.3 after the date of such agreement instead receive the corresponding percentage sublicense revenue under Section 8.5(a) from EOS. In order for Advenchen to effectively exercise its option under this Section 8.5(b), Advenchen must provide written notice to EOS of its decision to exercise within *** (***) days of Advenchen’s receipt of notice from EOS regarding the execution of the applicable sublicense agreement. In the event that Advenchen fails to exercise its notice in a timely fashion, the above terms with respect to the removal of milestones shall automatically become effective. For clarity, this Section 8.5(b) only applies when the Sublicense Revenues of Section 8.5(a) is greater than the Milestone Payments in Section 8.2 or 8.3 of this Agreement. In the event that EOS enters into an agreement with a Commercialization Sublicensee and the amount to be payable under Section 8.5(a)(i) or 8.5(a)(ii) (as applicable) is less than all of then-unpaid milestone payments under Sections 8.2 and 8.3, then EOS or its applicable sublicensees must continue to make the payments under the terms of Sections 8.2 and 8.3 of this Agreement, but EOS or its applicable sublicensees shall have no obligations to provide any payments to Advenchen (or its Affiliates) under Section 8.5(a) of this Agreement, which shall have no further force or effect.

8.6 EOS Option Upon Change of Control . Upon a Change of Control of EOS, EOS (or its applicable successor or acquirer) shall have the option to pay to Advenchen a one-time fee of *** dollars ($***) in lieu of any fees that are then due and payable to Advenchen under the terms of Sections 8.2, 8.3 and 8.5(a). Upon payment of such one-time fee, Advenchen and its Affiliates shall be deemed to have expressly waived their rights to receive any additional payments under Sections 8.2, 8.3 and 8.5(a), the terms of Sections 8.2, 8.3 and 8.5(a) shall have no further force or effect, and EOS and its applicable sublicensees shall have no further payment obligations under Sections 8.2, 8.3 and 8.5(a) on a forward-going basis. However, for clarity, the foregoing shall not discharge any other of EOS’s payment obligations under this Agreement, including but not limited to, the payment of royalties under Section 8.4.

8.7 No Projections . Advenchen and EOS acknowledge and agree that nothing in this Agreement shall be construed as representing an estimate or projection of anticipated sales of any Product, and that the milestones and Net Sales levels set forth in Sections 8.2 and 8.3 or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the milestone payments and royalty obligations to Advenchen in the event such milestones and/or Net Sales levels are achieved. NEITHER ADVENCHEN NOR EOS MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY COMMERCIALIZE ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF SUCH PRODUCT WILL BE ACHIEVED.

 

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ARTICLE 9

PAYMENTS

9.1 Royalty Reports and Payment . Within thirty (30) business days following the end of each calendar quarter during the Term, EOS or its applicable sublicensees shall provide Advenchen with a report containing the following information for the applicable calendar quarter: (a) the amount of gross sales of Product in the Licensed Territory, an itemized calculation of Net Sales in the Licensed Territory showing deductions, to the extent practicable, provided for in the definition of “Net Sales,” a calculation of the royalty payment due on such sales, an accounting of the number of units and prices for Product sold, the exchange rate for each country in which Product was sold, the application of the reductions, if any, made in accordance with the terms of Section 8.4(b); (b) the Sublicensing Revenue paid to EOS during the applicable calendar quarter and calculations of deductions or adjustments, to the extent practicable, provided for in the definition of “Sublicensing Revenue”; and (c) any other information reasonably required for the purpose of calculating royalties and other amounts due under this Agreement. Within ten (10) business days following its receipt of such report, Advenchen shall review and record such information as it determines necessary under its internal financial reporting procedures. Within sixty (60) business days following the end of each calendar quarter, EOS shall provide Advenchen with a report containing the information described above in respect of such calendar quarter for Advenchen’s review and confirmation within two (2) business days from receipt. In the event that either party determines that the calculation of Net Sales or Sublicensing Revenue for a calendar quarter deviates from the amounts previously reported to Advenchen for any reason (such as, on account of additional amounts collected or Product returns), EOS and Advenchen shall reasonably cooperate to reconcile any such deviations to the extent necessary under applicable legal or financial reporting requirements. Within twenty (20) business days following Advenchen’s written confirmation of the applicable quarterly report, EOS shall pay all amounts due to Advenchen hereunder.

9.2 Foreign Exchange . The rate of exchange to be used in computing the amount of currency equivalent in Dollars owed to a Party under this Agreement shall be the monthly average exchange rate between each currency of origin and U.S. Dollars as reported by Bloomberg or an equivalent resource as agreed by the Parties.

9.3 Payment Method; Late Payments . All payments due to Advenchen hereunder shall be made in U.S. Dollars by wire transfer of immediately available funds into an account designated by Advenchen. If Advenchen does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to Advenchen until the date of payment at the per annum rate of two percent (2%) over the then-current prime rate quoted by Citibank in New York City or the maximum rate allowable by applicable Law, whichever is lower.

9.4 Records; Audits . EOS will maintain complete and accurate records in sufficient detail to permit Advenchen to confirm the accuracy of the calculation of royalty and other payments under this Agreement. Upon reasonable prior notice, such records shall be available during regular business hours for a period of three (3) years from the end of the calendar year to which they pertain for examination at the expense of Advenchen, and not more often than once

 

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each calendar year, by an independent certified public accountant selected by Advenchen and reasonably acceptable to EOS, for the sole purpose of verifying the accuracy of the financial reports furnished by EOS pursuant to this Agreement. Any such auditor shall not disclose EOS’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by EOS or the amount of payments due by EOS under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 9.3) from the original due date. Any amounts shown to have been overpaid shall be refunded within thirty (30) days from the accountant’s report. Advenchen shall bear the full cost of such audit unless such audit discloses an underpayment by EOS of more than five percent (5%) of the amount due, in which case EOS shall bear the full cost of such audit.

9.5 Taxes .

(a) Cooperation and Coordination . The Parties acknowledge and agree that it is their mutual objective and intent to appropriately calculate, to the extent feasible and legal, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use all Commercially Reasonable Efforts to cooperate and coordinate with each other to achieve such objective.

(b) Payment of Tax . A Party receiving a payment pursuant to this Article 9 shall pay any and all taxes levied on such payment. If applicable Laws require that taxes be deducted and withheld from a payment made pursuant to this Article 9, the remitting Party shall (i) deduct those taxes from the payment; (ii) pay the taxes to the proper taxing authority; and (iii) send evidence of the obligation together with proof of payment to the other Party within sixty (60) days following that payment.

(c) Tax Residence Certificate . A Party (including any entity to which this Agreement may be assigned, as permitted under Section 17.5) receiving a payment pursuant to this Article 9 shall provide the remitting Party appropriate certification from relevant revenue authorities that such Party is a tax resident of that jurisdiction, if such receiving Party wishes to claim the benefits of an income tax treaty to which that jurisdiction is a party. Upon the receipt thereof, any deduction and withholding of taxes shall be made at the appropriate treaty tax rate.

(d) Assessment . Either Party may, at its own expense, protest any assessment, proposed assessment, or other claim by any Governmental Authority for any additional amount of taxes, interest or penalties or seek a refund of such amounts paid if permitted to do so by applicable Law. The Parties shall cooperate with each other in any protest by providing records and such additional information as may reasonably be necessary for a Party to pursue such protest.

 

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ARTICLE 10

INTELLECTUAL PROPERTY MATTERS

10.1 Prosecution of Patents .

(a) Advenchen Patents . The Advenchen Patents in existence as of the Effective Date are listed in Exhibit C hereto. The Parties shall update such Exhibit as appropriate (and at least once per calendar quarter) to add to Exhibit C each Patent filed after the Effective Date by Advenchen or its Affiliates (or by EOS on Advenchen’s behalf) which would constitute an Advenchen Patent hereunder. Except as otherwise provided in this Section 10.1(a), as between the Parties, EOS shall have the sole right and authority to prepare, file, prosecute and maintain the Advenchen Patents on a worldwide basis except for outside of the Licensed Territory. Such Advenchen Patents shall be filed in the name of Advenchen, or under a company name or individual’s name as directed by Advenchen, and all rights thereto shall be in and remain in the name of Advenchen, or other company or individual as determined by Advenchen. EOS shall bear all costs of preparation, filing, prosecution and maintenance of Advenchen Patents in the Licensed Territory (except for those patent applications, as provided below, which EOS has elected not to file, prosecute or maintain, and instead Advenchen has filed and is prosecuting and maintaining). As used herein, “prosecution” of such Patents shall include, without limitation, all communication and other interaction with any patent office or patent authority having jurisdiction over a patent application in connection with pre-grant proceedings. Post-grant proceedings shall be governed by Section 10.6(b). EOS shall provide Advenchen reasonable opportunity to review and comment on such efforts regarding such Advenchen Patents in the Licensed Territory, including by providing Advenchen with a copy of material communications from any patent authority in the Licensed Territory regarding such Advenchen Patent, and by providing drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. If EOS determines in its sole discretion to abandon or not maintain any Advenchen Patent(s) that is being prosecuted or maintained by EOS in the Licensed Territory, or to not file for rights in any particular country with respect to any Advenchen Patent(s), then EOS shall provide Advenchen with written notice of such determination within a period of time reasonably necessary to allow Advenchen to determine its interest in such Advenchen Patent(s) (including foreign filings). In the event Advenchen provides written notice expressing its interest in obtaining such Advenchen Patent(s), EOS shall transfer to Advenchen the responsibility of filing, prosecuting and/or maintaining the applicable Advenchen Patent(s). Advenchen shall thereafter bear all costs of preparation, filing, prosecution and maintenance of such Advenchen Patent(s).

(b) Cooperation in Prosecution . Advenchen shall, and shall cause its Affiliates to, provide EOS all reasonable assistance and cooperation in the Patent prosecution efforts provided above in this Section 10.1, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution, provided however, Advenchen’s assistance and cooperation shall be at no cost to Advenchen, and EOS shall reimburse Advenchen for all reasonable external costs ( e.g. , filing fees and attorney fees) associated with such assistance and cooperation. All communications between the Parties relating to the preparation, filing, prosecution or maintenance of the Advenchen Patents, including copies of any draft or final documents or any communications received from or sent to patent offices or patenting authorities with respect to such Patents, shall be considered Confidential Information and subject to the confidentiality provisions of Article 13.

 

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10.2 Patent Term Extensions in the Licensed Territory . The Parties agree to cooperate in an effort to avoid loss of any Patent rights which may otherwise be available to the Parties hereto under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the U.S., including by executing any documents as may be reasonably required. In particular, Advenchen agrees to cooperate with EOS, and to take any necessary actions, in obtaining patent term restoration or supplemental protection certificates or their equivalents in any country and region where applicable to the Advenchen Patents, including permitting EOS to proceed with applications for such in the name of Advenchen, if so required.

10.3 Infringement of Patents by Third Parties .

(a) Notification . Each Party shall promptly notify the other Party in writing of any existing or threatened infringement of the Advenchen Patents of which it becomes aware, and shall provide all evidence in such Party’s possession demonstrating such infringement.

(b) Infringement of Advenchen Patents .

(i) If a Third Party infringes any Advenchen Patent in the Licensed Territory by making, using, importing, offering for sale or selling the Product or a competitive product (a “ Product Infringement ”), each Party shall share with the other Party all Information available to it regarding such alleged infringement. EOS shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Product Infringement in the Licensed Territory, subject to Section 10.3(b)(ii) through 10.3(b)(v), below.

(ii) EOS shall have a period of ninety (90) days after the first notice under 10.3(a) to elect to enforce such Advenchen Patent against such Product Infringement. In the event EOS does not so elect, EOS shall so notify Advenchen in writing, and Advenchen shall have the right, but not the obligation, to commence a suit or take action to enforce the applicable Patent against such Third Party perpetrating such Product Infringement in the Licensed Territory at its own cost and expense. If one Party elects to bring suit or take action against the Product Infringement, then the other Party shall have the right, prior to commencement of the trial, suit or action, to join any such suit or action.

(iii) Each Party shall provide to the Party enforcing any such rights under this Section 10.3(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Law to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, and shall seek consent of the other Party in any important aspects of such enforcement including, without limitation, determination of litigation strategy, filing of important papers to the competent court, which shall not be unreasonably withheld or delayed.

 

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(iv) Each Party shall bear all of its own internal costs incurred in connection with its activities under this Section 10.3(b); provided, that in the event that the Parties are joined in suit or action against the Product Infringement and represented by the same outside counsel, then the Parties shall share equally in the external costs and expenses for such action.

(v) The Party not bringing an action with respect to Product Infringement in the Licensed Territory under this Section 10.3(b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.

(c) Settlement . EOS shall not settle any claim, suit or action that it brought under this Section 10.3 involving Advenchen Patents without the prior written consent of Advenchen, which consent shall not be unreasonably withheld or delayed.

(d) Allocation of Proceeds . If either Party recovers monetary damages from any Third Party in a suit or action brought under Sections 10.3(b) or 10.6(b), such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amounts shall be split as follows: (i) if such suit or action is initiated or defended by EOS, such amounts shall be retained by EOS and treated as Net Sales for purposes of the royalties due to Advenchen under this Agreement, or (ii) if such suit or action was initiated or defended by Advenchen, such amounts shall be allocated ***% to Advenchen and ***% to EOS.

10.4 Infringement of Third Party Rights in the Licensed Territory . If any Product used or sold by either Party, its Affiliates, licensees or sublicensees becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction within the Licensed Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, the Parties may agree on and enter into an “identity of interest agreement” wherein such Parties would agree to their shared, mutual interest in the outcome of such potential dispute.

10.5 Patent Marking . EOS (or its Affiliate, sublicensee or distributor) shall mark Products marketed and sold by EOS (or its Affiliate, sublicensee or distributor) hereunder with appropriate patent numbers or indicia at Advenchen’s reasonable request; provided, however, that EOS shall only be required to so mark such Products to the extent such markings or such notices would impact recoveries of damages or equitable remedies available under applicable law with respect to infringements of patents in the Licensed Territory.

10.6 Patent Oppositions and Other Proceedings .

(a) Third-Party Patent Rights . If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent owned or controlled by a Third Party and having one or more claims that covers the Product, or the use, sale, offer for sale or importation of the Product, such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. EOS shall have the exclusive right, but not the obligation, to bring at its own expense and in its sole control such action in the Licensed Territory. If EOS does not

 

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bring such an action in the Licensed Territory, within *** (***) days of notification thereof pursuant to this Section 10.6(a) (or earlier, if required by the nature of the proceeding), then Advenchen shall have the right, but not the obligation, to bring, at Advenchen’s sole expense, such action. The Party not bringing an action under this Section 10.6(a) shall be entitled to separate representation in such proceeding by counsel of its own choice and at its own expense, and shall cooperate fully with the Party bringing such action. Any awards or amounts received in bringing any such action shall be first allocated to reimburse the initiating Party’s expenses in such action, and any remaining amounts shall be retained by such Party.

(b) Parties’ Patent Rights . If any Advenchen Patent becomes the subject of any proceeding commenced by a Third Party within the Licensed Territory in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or enforceability thereof (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, an action for infringement against a Third Party under Section 10.3, in which case the provisions of Section 10.3 shall govern), then the Party responsible for filing, preparing, prosecuting and maintaining such Patent as set forth in Section 10.1 hereof, shall control such defense at its own cost and expense. The controlling Party shall permit the non-controlling Party to participate in the proceeding to the extent permissible under applicable Law, and to be represented by its own counsel in such proceeding, at the non-controlling Party’s expense. If either Party decides that it does not wish to defend against such action, then the other Party shall have a backup right to assume defense of such Third-Party action at its own expense. Any awards or amounts received in defending any such Third-Party action shall be allocated between the Parties as provided in Section 10.3(d).

10.7 Patent Validity Challenges . EOS, and any sublicensees, shall not file any lawsuits, oppositions, or other proceedings calling into question or attacking the validity of any Advenchen Patents.

ARTICLE 11

REPRESENTATIONS AND WARRANTIES

11.1 Mutual Representations and Warranties . Each Party hereby represents, warrants, and covenants (as applicable) to the other Party as follows:

(a) Corporate Existence and Power . As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted by it hereunder.

(b) Authority and Binding Agreement . As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

 

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(c) No Conflict; Covenant . It is not a party to any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under the Agreement.

(d) No Debarment . In the course of the development of Products, each Party shall not use, during the Term, any employee or consultant who has been debarred by any Regulatory Authority, or, to the Best Knowledge of such Party, is the subject of debarment proceedings by a Regulatory Authority.

11.2 Additional Representations and Warranties of Advenchen . Advenchen represents and warrants, on its behalf and on behalf of each of its Affiliates, to EOS as follows:

(a) Advenchen Patents . Exhibit C sets forth a complete and accurate list of all Advenchen Patents in existence as of the Effective Date. Advenchen is the sole and exclusive owner of all of the Advenchen Patents and is listed in the records of the appropriate United States and/or foreign governmental agencies as the sole and exclusive owner of record for each registration, grant and application included in the Advenchen Patents.

(b) Advenchen Know-How . To Advenchen’s Best Knowledge, Advenchen is the sole and exclusive owner of all of the Advenchen Know-How. Advenchen has the right to use and disclose and to enable EOS to use and disclose (in each case under appropriate conditions of confidentiality) the Advenchen Know-How. Advenchen has taken all reasonable precautions to preserve the confidentiality of the Advenchen Know-How, and has not disclosed to any Third Party any Advenchen Know-How that is or was confidential.

(c) No Out-Bound Agreements . Advenchen has not granted any Third Party (including any academic organization or agency), or any Affiliate of Advenchen, any rights to the Product (except for non-exclusive rights outside of the Licensed Territory).

(d) Proper Assignment of Rights . Advenchen has obtained from all individuals who participated in any respect in the invention or authorship of any Advenchen Technology effective assignments of all ownership rights of such individuals in such Advenchen Technology, either pursuant to written agreement or by operation of law.

(e) Sufficiency of Advenchen Technology . As of the Effective Date, to Advenchen’s Best Knowledge, the Advenchen Technology constitutes all intellectual property necessary for, and no Third Party Know-How (including Third Party materials) is needed to, Develop, Manufacture, use, make, have made, sell, offer for sale, have sold, Distribute, import and otherwise Commercialize the Product in the Field in the Licensed Territory.

(f) Non-Infringement of Advenchen Technology by Third Parties . As of the Effective Date, to Advenchen’s Best Knowledge, there are no ongoing activities by Third Parties that would constitute infringement or misappropriation of the Advenchen Technology within the Licensed Territory.

 

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(g) Non-Infringement of Third Party Rights . As of the Effective Date, to Advenchen’s Best Knowledge, none of the manufacture, use or the sale of the Compound in the Licensed Territory infringes any claim of an existing Patent owned by a Third Party or infringes or misappropriates any other Third Party intellectual property.

(h) Non-Claims of Third Party Rights . As of the Effective Date, Advenchen has not received any verbal or written claim or demand of any person or entity that the manufacture, use, or sale of the Compound in the Licensed Territory infringes a Third Party Patent or infringes or misappropriates any other Third Party intellectual property.

(i) Advenchen Patents Not Invalid or Unenforceable . To Advenchen’s Best Knowledge, the Advenchen Patents are valid and enforceable. Advenchen has not taken any action or failed to take any action, which action or failure reasonably could be expected to result in the abandonment, cancellation, forfeiture, relinquishment, invalidation or unenforceability of any of the Advenchen Patents. As of the Effective Date, the Advenchen Patents exist, and Advenchen has not received any written notice from a Government Authority that the Advenchen Patents are invalid or unenforceable, in whole or in part.

(j) No Encumbrances . As of the Effective Date, all Patents and all Know-How owned by Advenchen or licensed from a Third Party that are necessary or useful to Develop, Commercialize and Distribute Compound in the Field and the Expanded Field in the Licensed Territory are free and clear of any encumbrance, lien, or claim of ownership or license by any Third Party.

(k) Disclosure . Prior to the Effective Date, Advenchen made available to EOS, or provided EOS with, copies of all information with respect to the Compound as requested by EOS in writing. In addition, as of the Effective Date Advenchen has disclosed to EOS any material information known to Advenchen as of such date with respect to (i) the safety of the Compound, (ii) the efficacy of such Compound, (iii) any then existing circumstance which would be reasonably likely to prohibit or prevent the Development, Manufacturing and/or Commercialization of the Compound in the Licensed Territory.

(l) Non-Action or Claim . As of the Effective Date, to Advenchen’s Best Knowledge, there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving the Compound and/or the Advenchen Technology relating to the Compound by or against Advenchen or any of its Affiliates in or before any court, governmental or regulatory authority. In particular, as of the Effective Date, to its Best Knowledge, there is no pending or threatened product liability actions involving the Compound. As of the Effective Date, to Advenchen’s Best Knowledge, there are no claims, judgments or settlements against or owed by Advenchen relating to the Advenchen Technology or the Compound.

(m) Development Documentation and Studies . As of the Effective Date, all inventions included or described in the Advenchen Patents were conceived and reduced to practice by Advenchen in the United States. All studies conducted with respect to the Compound, including such studies from which the Development Documentation in Exhibit A are derived, have been conducted by Advenchen substantially in accordance with applicable Laws

 

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by persons with appropriate education, knowledge and experience. As of the Effective Date, Advenchen has not been debarred and is not subject to debarment, in each case pursuant to Section 306 of the FD&C Act or any similar law or regulation in any jurisdiction outside the U.S.

11.3 No Other Representations or Warranties . EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

ARTICLE 12

INDEMNIFICATION

12.1 Indemnification by Advenchen . Advenchen shall defend, indemnify, and hold EOS and EOS’s officers, directors, employees, and agents (the “ EOS Indemnitees ”) harmless from and against any and all Third Party claims, suits, proceedings, damages, expenses (including court costs and reasonable attorneys’ fees and expenses), and recoveries (collectively, “ Claims ”) to the extent that such Claims arise out of, are based on, or result from (a) the Development, Manufacture, storage, handling, Distribution, use, promotion, sale, offer for sale, and importation of Products by Advenchen or its Affiliates, or its or their sublicensees (other than EOS), or distributors (other than EOS), or (b) the breach of any representation, warranty or covenant of Advenchen or its Affiliates in this Agreement, or (c) the breach of any representations or warranties made under Sections 11.2(b) and 11.2(g) notwithstanding that Advenchen was unaware of the underlying facts that serve as a basis for breach; or (d) the willful misconduct or negligent acts of Advenchen, its Affiliates, or the officers, directors, employees, or agents of Advenchen or its Affiliates. The foregoing indemnity obligation shall not apply to the extent that (i) the EOS Indemnitees fail to comply with the indemnification procedures set forth in Section 12.3 and Advenchen’s defense of the relevant Claims is prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity for which EOS is obligated to indemnify the Advenchen Indemnitees under Section 12.2.

12.2 Indemnification by EOS . EOS shall defend, indemnify, and hold Advenchen and Advenchen’s officers, directors, employees, and agents (the “ Advenchen Indemnitees ”) harmless from and against any and all Claims to the extent that such Claims arise out of, are based on, or result from (a) the Development, Manufacture, storage, handling, Distribution, use, promotion, sale, offer for sale, and importation of Products by EOS or its Affiliates, or its or their sublicensees, or distributors, or (b) the breach of any representation, warranty or covenant of EOS or its Affiliates set forth in this Agreement, or (c) the willful misconduct or negligent acts of EOS or its Affiliates, or the officers, directors, employees, or agents of EOS or its Affiliates. The foregoing indemnity obligation shall not apply to the extent that (i) the Advenchen Indemnitees fail to comply with the indemnification procedures set forth in Section 12.3 and EOS’s defense of the relevant Claims is prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity for which Advenchen is obligated to indemnify the EOS Indemnitees under Section 12.1.

 

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12.3 Indemnification Procedures . The Party claiming indemnity under this Article 12 (the “ Indemnified Party ”) shall give written notice to the Party from whom indemnity is being sought (the “ Indemnifying Party ”) in a reasonably timely manner after learning of such Claim. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the claim with counsel of its choice. The Indemnifying Party shall not settle any claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money. So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle any such claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (a) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Article 12.

12.4 Limitations of Liability .

(a) Limitation of Liability for Certain Breaches By Advenchen . SOLELY WITH RESPECT TO A BREACH OF SECTION 12.1(C) ABOVE, ADVENCHEN WILL NOT BE LIABLE UNDER THIS AGREEMENT TO EOS FOR ANY AMOUNTS IN EXCESS OF AN AMOUNT EQUAL TO THE AGGREGATE AMOUNTS ACTUALLY PAID BY EOS TO ADVENCHEN HEREUNDER AS OF THE DATE EOS PROVIDES WRITTEN NOTICE TO ADVENCHEN OF A CLAIM FOR LIABILITY UNDER SECTION 12.1(C); PROVIDED THAT ADVENCHEN SHALL ONLY BE OBLIGATED TO INITIALLY PAY *** PERCENT (***%) OF THE AMOUNT SET FORTH IN THE CLAIM SUBMITTED BY EOS PURSUANT TO SECTION 12.3, WITH THE REMAINDER OF THE AMOUNT SUBJECT TO A CREDIT GRANTED TO EOS AGAINST ANY PAYMENTS DUE TO ADVENCHEN UNDER THIS AGREEMENT SUBSEQUENT TO THE DATE OF WRITTEN NOTICE. FOR AVOIDANCE OF DOUBT, THE FOREGOING LIMITATION OF LIABILITY SHALL NOT APPLY TO ANY OTHER CLAIMS UNDER THIS SECTION 12 (INCLUDING SECTION 12.1(B)) OR OTHERWISE.

(b) General Limitations . NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 12.4(B) IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 12.1 OR 12.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 13.

 

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12.5 Insurance . Each Party shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold by such Party. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 12. Each Party shall provide the other Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder.

ARTICLE 13

CONFIDENTIALITY

13.1 Confidentiality . Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties during a period that is the longer of (i) the Term, or (ii) *** (***) years from the Effective Date, each Party agrees that it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information furnished to it by the other Party pursuant to this Agreement except for that portion of such information or materials that the receiving Party can demonstrate by competent written proof:

(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

(d) was disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure; or

(e) was independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

13.2 Authorized Disclosure . Each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following situations:

(a) prosecuting or defending litigation;

 

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(b) complying with applicable Laws;

(c) regulatory filings with the Securities and Exchange Commission or other relevant exchange on which such Party is listed;

(d) filings with Regulatory Authorities for Regulatory Approval;

(e) disclosure to its employees, agents, consultants, and any bona fide Third Party potential (sub)-licensees (including potential Third Party contract manufacturers and other licensees or collaborators) only on a need-to-know basis and solely as necessary in connection with the performance of or as otherwise contemplated by this Agreement, provided that in each case the recipient of such Confidential Information must agree to be bound by similar obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Article 13 prior to any such disclosure; and

(f) disclosure of the material terms of this Agreement to any bona fide potential investor, investment banker, acquiror, merger partner, licensees, sublicensees or other potential or actual financial or commercial partner; provided that in connection with such disclosure, the disclosing Party shall use all reasonable efforts to inform each recipient of the confidential nature of such Confidential Information and cause each recipient of such Confidential Information to treat such Confidential Information as confidential.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to clause (a) through (d) of this Section 13.2, it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use diligent efforts to secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder. Each Party will be responsible for any acts or omissions of any Third Party to which such Party discloses Confidential Information in accordance with this Section 13.2.

13.3 Publicity . Neither Party shall issue any press release or other publicity materials, or make any public presentation with respect to the terms or conditions of, this Agreement or the programs or efforts being conducted by the other Party hereunder, in each case without the prior written consent of the other Party. This restriction shall not apply to any future disclosures required by law or regulation, including as may be required in connection with any filings made with, or by the requirements of the securities exchange on which such Party’s securities are traded; provided, that the disclosing Party (i) use all reasonable efforts to inform the other Party at least three (3) business days prior to making any such disclosures and cooperate with the other Party in seeking a protective order or other appropriate remedy (including redaction), and (ii) whenever possible, request confidential treatment of such information. In addition, where required by Law of the applicable securities exchange upon which a Party may be listed, such Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Regulatory Approvals in the Licensed Territory as they occur, subject only to the review procedure set forth in the preceding sentence. In relation to the other Party’s review of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary, but shall not withhold its consent to disclosure of the information that the

 

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relevant milestone has been achieved and triggered a payment hereunder. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 13.3.

13.4 Publications .

(a) Any proposed written publications (including slide presentations at industry events) relating to a Product in the custody or control of Advenchen shall require the written consent of EOS prior to their release; provided, that the foregoing shall not apply to information which is not of a scientific or technical nature and which is in the public domain or any public disclosures required by law or governmental regulation or by the rules of any recognized stock exchange or quotation system.

(b) Notwithstanding any other provisions of this Agreement, each Party and/or any of their Affiliates shall have the right to disclose, publish and have published the existence of, and the results from, any clinical trials conducted under or related to the subject matter of this Agreement in accordance with its standard policies; provided, however, that such Party or the applicable Affiliate shall, wherever practicable, provide the other Party a reasonable opportunity to review in advance any such disclosure or publication and will reasonably consider any comments thereon provided by such other Party.

ARTICLE 14

TERM AND TERMINATION

14.1 Term . This Agreement shall (subject to Section 17.8) become effective on the Effective Date and, unless earlier terminated pursuant to this Article 14, shall remain in effect, on a Product-by-Product basis and on a country-by-country basis, until the expiration of the Royalty Term of such Product in such country.

14.2 Early Termination .

(a) Unilateral Termination by EOS Prior to ***. Prior to *** in the Licensed Territory, EOS shall have the right to terminate this Agreement, for any or no reason upon *** (***) days’ written notice, either (i) in its entirety, or (ii) country by country.

(b) Unilateral Termination by EOS After ***. Effective only after ***, EOS shall have the right to terminate this Agreement, for any or no reason, upon *** (***) days’ written notice to Advenchen, either (i) in its entirety, or (ii) country by country; provided, that no termination under this Section 14.2(b) shall become effective prior to the *** of such *** in the relevant country(ies).

(c) Unilateral Termination by EOS for ***. Effective only after the ***, EOS shall have the right to terminate this Agreement in its entirety or country by country upon *** (***) days’ written notice to Advenchen, if EOS determines in good faith that *** of the Product under this Agreement in its entirety or country by country is and will not be ***;

 

33.


provided, that no such termination shall become effective prior to (i) the *** of the *** in any country in the Licensed Territory, or (ii) *** (***) months following the *** in any country in the Licensed Territory in the case where an applicable Law of any Governmental Authority results in a *** of the Product which is not likely to abate before the *** of the *** in any country in the Licensed Territory. The determination of *** and *** under this Section 14.2(c) shall be made on the basis of Commercially Reasonable Efforts and taking into account financial projections suitable to support *** of the Product on the terms set forth in this Agreement.

14.3 Termination for Breach . Advenchen shall have the right to terminate this Agreement upon written notice to EOS for material breach by EOS of its obligations under this Agreement if, after receiving written notice identifying such material breach, EOS fails to cure such material breach within ninety (90) days from the date of such notice (or within sixty (60) days’ notice in the event such breach is solely based upon EOS’s failure to pay any undisputed amounts due Advenchen hereunder). EOS shall have the right to terminate this Agreement upon written notice to Advenchen for material breach by Advenchen of its obligations under this Agreement if, after receiving written notice identifying such material breach, Advenchen fails to cure such breach within ninety (90) days from the date of such notice (or within sixty (60) days’ notice in the event such breach is solely based upon Advenchen’s failure to pay or credit any undisputed amounts due EOS hereunder).

14.4 Unilateral Termination by Advenchen for Failure to Develop . Prior to First Commercial Sale in the Licensed Territory, Advenchen shall have the right to terminate this Agreement upon written notice to EOS in the event that EOS fails to conduct any Development (as reasonably evidenced by written documentation) during a consecutive *** (***) month period, if, after receiving written notice identifying such failure, EOS is unable to demonstrate within thirty (30) days from the date of such notice, to Advenchen’s reasonable satisfaction, that it has in fact conducted Development during such period.

14.5 Termination for Safety . EOS shall have the right to terminate this Agreement with at least thirty (30) days written notice at any time (a) if senior executives responsible for EOS’s Pharmacoviligence and Clinical Science functions determine in good faith and in consideration of Commercially Reasonable Efforts that the risk/benefit profile of the Product is such that the Product cannot continue to be Developed or administered to patients safely (and not for commercial reasons), or (b) upon the occurrence of serious adverse events related to the use of Product that cause EOS to reasonably conclude that the continued use of Product by patients will result in patients being exposed to a product in which the risks outweigh the benefits. Upon any such termination, the Parties shall reasonably cooperate with each other in the wind-down and/or, if applicable, transition of all the activities from EOS to Advenchen, or such Third Party designated by Advenchen, and the provisions of Section 14.7(a) and (b) shall apply.

14.6 Continuing Rights of Commercialization Sublicensees . Upon any termination of any license rights granted to EOS under this Agreement, each sublicense previously granted by EOS or any of its Affiliates under such license rights to any Commercialization Sublicensee shall remain in effect and shall become a direct license or sublicense, as the case may be, of such rights by Advenchen to such Commercialization Sublicensee, subject to the Commercialization Sublicensee agreeing in writing to assume SOS’s terms, conditions and obligations to Advenchen under this Agreement as they pertain to the sublicensed rights.

 

34.


14.7 Effect of Termination for EOS . The following provisions shall apply if (i) EOS terminates this Agreement in its entirety or with respect to certain countries pursuant to Section 14.2(a), (b), or (c), or (ii) Advenchen terminates this Agreement in its entirety under Section 14.3 due to EOS’s material uncured breach, and following a final, non-appealable judgment pursuant to Section 16.4 of EOS’s material breach of this Agreement (unless EOS in writing does not dispute Advenchen’s determination of EOS’s material breach):

(a) Outstanding Obligations . EOS shall be responsible for any outstanding payment obligations of EOS that existed or accrued prior to the effective date of termination with respect to the terminated countries.

(b) Right of First Negotiation . Advenchen will have a right of first negotiation, exercisable by written notice to EOS at any time within *** (***) days of such termination, (i) to obtain a worldwide, exclusive, royalty-bearing license, with the right to sublicense, under the EOS Patents, to Develop, Manufacture, make, have made, use, sell, have sold, offer for sale and import the Product, and (ii) to receive copies of all EOS Development Documentation and, to the extent permitted by applicable Laws, obtain an agreement by EOS to transfer and assign to Advenchen all Regulatory Materials, Regulatory Approvals, and related data relating to Products throughout the Licensed Territory or in the terminated countries, as applicable, as and to the extent owned or Controlled by EOS, each of (i) and (ii) on commercially reasonable terms to be negotiated in good faith by the Parties for up to an additional ninety (90) days following exercise of such right of first negotiation.

(c) Termination of Licenses . For clarity, upon any termination of this Agreement by EOS under Section 14.2(a), (b), or (c), or by Advenchen under Section 14.3, the licenses granted to EOS under this Agreement for such terminated country(ies) shall terminate.

(d) Partial Termination . In the event of a termination by EOS under Section 14.2(a), (b), or (c) for a particular country, such country shall be deemed excluded from the definition of Licensed Territory.

14.8 Effect of Termination for Advenchen . If EOS has the right to terminate this Agreement pursuant to Section 14.3 and elects not to exercise such right, then, in addition to any other rights and obligations under Section 14.3 or otherwise under this Agreement with respect to such termination, Advenchen shall continue to be liable to EOS for any uncured material breach, and EOS shall be entitled to pursue all legal and equitable remedies arising from such material breach that are available to it. Following a final, non-appealable judgment pursuant to Section 16.4 (unless Advenchen in writing does not dispute EOS’s determination of Advenchen’s material breach), of Advenchen’s material breach of this Agreement, EOS may elect, in lieu of receiving a payment of such damages from Advenchen, to offset EOS’s future payment obligations to Advenchen under this Agreement by the amount of damages determined and awarded to EOS pursuant to Section 16.4 (or agreed to in writing by the Parties pursuant to Section 16.2).

 

35.


14.9 Rights in Bankruptcy .

(a) EOS Bankruptcy Events . If EOS becomes insolvent, executes an assignment for the benefit of creditors, ceases operations, dissolves or becomes subject to bankruptcy or receivership proceedings, to the extent permitted by Law, this Agreement shall automatically terminate and all rights, including intellectual property and patent rights granted to EOS, shall automatically revert to Advenchen. To the extent reasonably possible, EOS shall notify Advenchen prior to becoming insolvent, executing an assignment for the benefit of credits, ceasing operations, dissolving, or becoming subject to bankruptcy or receivership proceedings, and Advenchen shall have the right to immediately terminate the Agreement and retain all intellectual property rights, including rights in the Advenchen patents.

(b) Advenchen Bankruptcy Events . All rights and licenses granted under or pursuant to this Agreement by Advenchen are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that EOS, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Advenchen under the U.S. Bankruptcy Code, EOS shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in EOS’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon EOS’s written request therefor, unless Advenchen elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by Advenchen upon written request therefor by EOS.

14.10 Survival . The following provisions shall survive any expiration or termination of this Agreement for the period of time specified in the applicable Section or, if no time is specified, indefinitely: Articles 1, 8 (solely with respect to payments that are due as of the effective date of such expiration or termination, or that become due in connection with such expiration or termination), 9, 11, 12, 13, 16 and 17, and Sections 10.1, 14.6, 14.7, 14.8, 14.9 and 14.10. Termination or expiration of this Agreement for any reason shall not release a Party from any liability or obligation that already has accrued prior to such expiration or termination, nor affect the survival of any provision hereto to the extent it is expressly stated to survive such termination.

ARTICLE 15

EXPANDED FIELD

15.1 Right of First Negotiation . Advenchen hereby grants, and shall cause each of its Affiliates to grant, to EOS an exclusive right of first negotiation (ROFN) with respect to the Expanded Field Assets ( e.g ., a right to Develop and/or Commercialize a Product for an indication not included in the Field). No later than six (6) months from the Effective Date, Advenchen will provide EOS all information and documents it has in its possession regarding the Expanded Field Assets. EOS shall have thirty (30) days from the receipt of such information and

 

36.


documents (or seven (7) months from the Effective Date, whichever is later) to determine if it is interested in licensing in the Expanded Field, and to provide written notice to Advenchen of its intention to negotiate a license in good faith (“ ROFN Notice ”). If EOS determines that it is not interested in licensing the Expanded Field Assets or does not provide the ROFN Notice in the required time, then Advenchen is free to negotiate an agreement with a Third Party without any further obligation to EOS, other than those provided in Section 15.4. However, if EOS gives the ROFN Notice indicating its intention to negotiate for the rights in the Expanded Field, the Parties shall have ninety (90) days from the ROFN Notice to reach an agreement with respect to the Expanded Field Assets (“ ROFN Period ”). If no agreement is reached, and both Parties have not agreed to an extension of time to the ROFN Period, then Advenchen is free to negotiate with Third Parties without any further obligation to EOS (other than those provided in Section 15.4). However, in no event shall Advenchen give a Third Party more favorable terms than what EOS has offered for the Expanded Field Assets.

15.2 Maintenance of Expanded Field Assets . Prior to the expiration or termination of the ROFN Period, Advenchen agrees to, and to cause each of its applicable Affiliates to, take all reasonable actions (at Advenchen’s or its Affiliates’ expense) to maintain and protect the applicable Expanded Field Assets, including filing and maintaining patent applications in accordance with applicable Laws and using reasonable measures to protect applicable trade secrets. In the event that Advenchen determines, in good faith, to abandon or otherwise forego maintenance any material Expanded Field Asset before the expiration or termination of the ROFN Period, Advenchen shall first provide EOS with written notice of such determination within a period of time reasonably necessary to allow EOS to determine whether it would like to obtain an interest in such Expanded Field Asset.

15.3 No Third Party Collaboration . Prior to expiration or termination of the ROFN Period, Advenchen shall not sell, transfer, dispose of, enter into a Third Party Collaboration with respect to or grant or permit to exist any encumbrance (including any security interests, liens or licenses) on any of the applicable Expanded Field Assets.

15.4 Competitive Sales . Advenchen shall pay to EOS, on a quarterly basis, a running royalty equal to *** percent (***%) of net Competitive Sales in the Licensed Territory made under a Third Party agreement for the Expanded Field Assets. Advenchen will maintain complete and accurate records in sufficient detail to permit EOS to confirm the accuracy of the calculation of royalty payments under this Section 15.4. “ Competitive Sales ” means sales of a Product in the Expanded Field which give rise to off-label uses that are within the Field, whereby such sales have a market share of at least *** percent (***%) of the market (in units) for the Product in a given country (as reasonably demonstrated by EOS, Advenchen’s or its authorized sublicensees’ sales data, or any reputable Third Party market source).

ARTICLE 16

DISPUTE RESOLUTION

16.1 Disputes . The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes

 

37.


arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 16 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

16.2 Early Resolution By the Parties . With respect to all disputes arising between the Parties, including, without limitation, any alleged failure to perform, or breach of, this Agreement, or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Designated Executive for each Party for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. With respect to any dispute regarding an alleged material breach of this Agreement and termination under this Section 16.2, if such dispute is not resolved by such Designated Executives within such period, then either Party may submit such dispute to binding arbitration in accordance with Section 16.4.

16.3 Injunctive Relief . Nothing herein may prevent either Party from seeking a preliminary injunction or temporary restraint order in order to prevent any Confidential Information from being disclosed without appropriate authorization under this Agreement.

16.4 Arbitration . Any and all disputes arising out of our in connection with this Agreement shall be finally resolved by arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce before an Arbitral Tribunal of three (3) arbitrators. Each Party shall nominate one (1) arbitrator for confirmation, with the third arbitrator to be jointly nominated by the two co-arbitrators within thirty (30) days of the confirmation of the second arbitrator. If the two co-arbitrators do not nominate the third arbitrator within that period, then the third arbitrator shall be appointed by the ICC Court. All the arbitrators must be lawyers and fluent in English. The arbitration proceedings shall take place in Zurich (Switzerland) and shall be conducted in the English language, without prejudice to the Parties’ right to deposit documentation in Italian or in any other foreign language, provided that any of the said documents is accompanied by the relevant translation into English, as well as to be heard and/or have their witnesses examined in their native language, with direct audio recording and subsequent transcription and translation into English of the said deposition or witness deposition. The arbitral award shall be drafted in English. The Arbitral Tribunal’s award shall be final and binding and enforceable in any court of competent jurisdiction.

ARTICLE 17

MISCELLANEOUS

17.1 Entire Agreement; Amendment . This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof; provided, that the Confidentiality Disclosure Agreement between the Parties dated November 27, 2007, shall continue in full force and effect in accordance with its

 

38.


terms. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

17.2 Force Majeure . Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the control of the Parties, including without limitation, an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). If a force majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

17.3 Notices . Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 17.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by confirmed facsimile or a reputable courier service, or (b) five (5) business days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.

 

If to Advenchen:  

Advenchen Laboratories LLC

9135 Reseda Boulevard, Suite 238

Northridge, California 91324

USA

Attn: Dr. Paul Chen

Fax: (626) 608-0397

 

If to EOS:  

Ethical Oncology Science S.p.A.

Via Monte di Pieta, 1/A

20121 Milan

Italy

Attn: Dr. Silvano Spinelli

Fax: +39 02 87391617

17.4 No Strict Construction; Headings . This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have

 

39.


authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.

17.5 Assignment . Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to Affiliates or to a successor to substantially all of the business of such Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other transaction. Any successor or assignee of rights and/or obligations permitted hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. The Advenchen Technology, in the case of Advenchen as assignor or transferor, or the EOS Technology, in the case of EOS as assignor or transferor, shall exclude any Patents and Information (a) Controlled by any permitted assignee or transferee prior to the effective date of such assignment or transfer of this Agreement to such assignee or transferee and (b) not developed in connection with any Product. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 17.5 shall be null, void and of no legal effect.

17.6 Performance by Affiliates . Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall otherwise cause its Affiliates to comply with the provisions of this Agreement. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

17.7 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

17.8 HSR Filing . Each of EOS and Advenchen agrees to prepare and make appropriate filings as necessary under the HSR Act relating to this Agreement and the transactions contemplated hereby as soon as reasonably practicable after the Effective Date (the “ HSR Filing Date ”). The Parties agree to cooperate in the antitrust clearance process and to furnish promptly to the Federal Trade Commission (FTC), the Antitrust Division of the Department of Justice and any other agency or authority, any information reasonably requested by them in connection with such filings. Other than the provisions of this Section 17.8 and Articles 13 and 16, the rights and obligations of the Parties under this Agreement shall not become effective until the waiting period provided by the HSR Act shall have terminated or expired without any action by any government agency or challenge to the transaction (the date of such termination or expiration shall be the “ Approval Date ” of this Agreement). Upon the occurrence of the Approval Date, if applicable, all provisions of this Agreement shall become effective automatically without the need for further action by the Parties. In the event that

 

40.


antitrust clearance from the FTC and Antitrust Division of the Department of Justice is not obtained within ninety (90) days after the HSR Filing Date, or such other date as the Parties may mutually agree, this Agreement maybe terminated by either Party. In the event a provision of this Agreement needs to be deleted or substantially revised in order to obtain regulatory clearance of this transaction, the Parties will negotiate in good faith in accordance with Section 17.9.

17.9 Severability . If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

17.10 No Waiver . Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

17.11 Independent Contractors . Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity. The relationship between Advenchen and EOS is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner, other than as may be expressly set forth in this Agreement. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

17.12 English Language; Governing Law . This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. This Agreement, including any claim or dispute arising out of or related to the interpretation, performance or termination thereof, shall be governed by and construed under the laws of the State of California, without giving effect to any choice of law principles that would require the application of the laws of a different state.

17.13 Counterparts . This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement shall be binding upon the delivery by each Party of an executed signature page to the other Party, which may include by facsimile transmission.

[ Signature Page Follows ]

 

41.


IN WITNESS WHEREOF , the Parties have executed this Agreement in duplicate originals by their duly authorized officers as of the Effective Date.

 

E THICAL O NCOLOGY S CIENCE S.P.A.     A DVENCHEN L ABORATORIES LLC
By:  

/s/ Silvano Spinelli

    By:  

/s/ Paul Chen

Name:   Dr. Silvano Spinelli     Name:   Dr. Paul Chen
Title:   Chief Executive Officer     Title:   Chief Executive Officer


EXHIBIT A-1

A DVENCHEN K NOW -H OW

 

1. Copies of all file histories and related documentation (including attorney files) for the Patents identified in Exhibit C .

 

2. The synthetic procedures (with experimental details and yields for each step) used to prepare the batches of the Compound that have been used to perform in vivo anti-tumor activity studies. The level of information should be similar to what is normally expected for a publication in a peer reviewed Journal.

 

3. Detailed description of the analytical procedures used to characterize the batches of the Compound that have been used to perform in vivo anti-tumor activity studies. The level of information should be sufficient to transfer the methodology to another testing laboratory.

 

4. Description of the synthetic procedures explored during the process optimization for the preparation of the Compound (description in this case can be a summary of findings) and conclusions summarizing the rationale behind the selection of the current process.

 

A-1


EXHIBIT A-2

A DVENCHEN K NOW -H OW

 

1. The complete description, on the highest scale, of the most advanced synthetic process used to prepare the preclinical batches including:

 

    all the experimental details and yields for each step;

 

    the description of the salt formation step;

 

    any analytical control or specification for reagents, raw materials, and intermediates; and

 

    any process control and related analytical method;

in order to allow EOS to be able to discuss in the regulatory documentation the differences between previous and the GMP batches.

 

2. Stability data on the Compound either as a salt or as a free base (or both if available) including:

 

    a description or a reference to the analytical methods used;

 

    a complete description of the immediate packaging material used; and

 

    the storage conditions and the time point tested.

 

3. Preliminary information gathered on the structure of the possible impurities if any.

 

4. The polymorph screening study and all experimental data relative to the existence of different polymorphs for the Compound as free base or as salt.

 

5. The salt screening study in support to the selection of the final salt form including:

 

    the counter-ions investigated;

 

    the solvent systems for the formation of solid/crystalline material;

 

    the analytical characterization (purity, stoichiometry, hygroscopicity, X-ray, etc.); and

 

    any stability and solubility data.

 

6. Pharmaceutical forms:

 

    complete description of the pharmaceutical forms administered to the animals in the in vivo studies (antitumor and pharmacokinetics);

 

    results for solubility screening if any; and

 

2.


    any preliminary pharmaceutical development studies.

 

7. In vivo pharmacology and pharmacokinetics studies:

 

    list of studies performed as of the effective date; and

 

    summary study reports (non-QC final drafts are acceptable). The level of information should be similar to what is normally expected for a publication in a peer reviewed Journal.

 

3.


EXHIBIT B

A DVENCHEN M ATERIALS

N ONE

 

B-1


EXHIBIT C

A DVENCHEN P ATENTS

 

Invention Title

   Case No.    Application
No.
   Patent
No.
  

Country

   Effe. Date    Issue
Date

Spiro Substituted Compounds As Angiogenesis Inhibitors

      60/894,693       United States of America    March 14, 2007   

Spiro Substituted Compounds As Angiogenesis Inhibitors

      60/941,699       United States of America    June 4, 2007   

Spiro Substituted Compounds As Angiogenesis Inhibitors

      12/036,245       United States of America    February 23, 2008   

Spiro Substituted Compounds As Angiogenesis Inhibitors

      PCT/US08/54817       PCT    February 24, 2008   

 

C-1


EXHIBIT D

P RODUCT D ESCRIPTION

The compound 6-(7-((1-Aminocyclopropyl)methoxy)-6-methoxyquinolin-4-yloxy)-N-methyl- 1-naphthamide having the following chemical structure (I):

 

LOGO

its salts with pharmaceutically acceptable salts, including but not limiting to the hydrochloride salt and the citrate salt, and pharmaceutical compositions containing the above compounds.

 

D-1-1


FIRST AMENDMENT

First Amendment, dated as of April 13, 2010 (the “ Amendment Effective Date ”) (this “ Amendment ”), to the Development and Commercialization Agreement entered into as of October 24, 2008 (the “ Agreement ”) between Advenchen Laboratories LLC (“ Advenchen ”) and Ethical Oncology Science S.P.A. (“ EOS ”).

RECITALS

WHEREAS, EOS and Advenchen are parties to the Agreement; and

WHEREAS, Advenchen and EOS wish to amend the Agreement in certain respects.

NOW, THEREFORE, in consideration of the foregoing and for good and valuable consideration EOS and Advenchen agree as follows:

ARTICLE 1

DEFINED TERMS

SECTION 1.01 Capitalized Terms . Capitalized terms not otherwise defined in this Amendment shall have the meanings ascribed thereto in the Agreement.

ARTICLE 2

AMENDMENTS TO AGREEMENT

SECTION 2.01 Amendments . The Agreement is hereby amended as follows:

(a) Section 1.1. Section 1.1 of the Agreement is hereby deleted in its entirety and replaced by “Intentionally Left Blank”.

(b) Advenchen Patent . The definition of Advenchen Patent set forth in Section 1.6 of the Agreement is hereby amended in full to read as follows:

“Advenchen Patent” means any Patent covering the Development, Manufacture (other than of intermediates covered by Exhibit F), use, sale, offer for sale, having sold, Distribution, import, or any other Commercialization of the Product that (a) is Controlled by Advenchen or its Affiliates as of the Effective Date or at any time during the Term, and (b) would, but for the license granted by Advenchen hereunder, be infringed by the Development, Manufacture, use, sale, offer for sale, having sold, Distribution, import, or any other Commercialization of the Product by or on behalf of EOS or its sublicensee(s) in the Field or the Expanded


Field (as applicable). Advenchen Patents shall include without limitation (i) those Patents listed on Exhibit C , and (ii) any patent issuing from an application claiming priority thereto or otherwise continuing therefrom.

(c) Competing Product . The definition of Competing Product set forth in Section 1.16 of the Agreement is hereby amended in full to read as follows:

 

  “1.16 “Competing Product” means:

 

  (i) A chemical compound comprised by the general formula of the patent applications listed in Exhibit C, including any patent issuing from an application claiming priority thereto or otherwise continuing therefrom, including, but not limited to, reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part or divisions.

Subject to clause (i), a “Competing Product” shall not mean the chemical compounds comprised by the general formula of the patent applications listed in Exhibit E List 1 and its corresponding national phase patent applications, including any patent issuing from an application claiming priority thereto or otherwise continuing therefrom, including, but not limited to, reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, and divisions (the “E List 1 Patents”); nor the chemical compounds which are the subject of the patent applications listed in Exhibit E List 2, and their corresponding national phase patent applications, reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, and divisions.”

(d) Notional Amount/E List 1 Products . Article I of the Agreement is hereby amended by adding the following definitions thereto:

“1.77 “Notional Amount” means (i) if the Milestone as set forth in Section 8.2(a)(i) has been paid, an amount equal to the interest that would accrue on a principal balance of $*** at an interest rate of ***% per annum commencing on the date of payment of such 8.2 (a)(i) milestone, plus (ii) if the Milestone set forth in Section 8.2(a)(ii) has been paid, an amount equal to the interest that would accrue on an additional principal balance of $*** at an interest rate of ***% per annum commencing on the date of payment of such 8.2(a)(ii) milestone plus (iii) if the Milestone set forth in Section 8.2(a)(iii) has been paid, an amount equal to the interest that would accrue on an additional principal balance of $*** at an interest rate of***% per annum commencing on the date of payment of such 8.2 (a)(iii) milestone plus (iv) if the Milestone set forth in Section 8.2(a)(iv) has been paid, an amount equal to the interest that would accrue on an additional principal balance of $***at an interest rate of ***% per annum commencing on the date of payment of such 8.2 (a)(iv) milestone.”

 

2


“1.78 “E List 1 Products” means each compound or product covered by the E List 1 Patents.”

(e) Section 2.4 . Section 2.4 of the Agreement is hereby amended in full to read as follows:

“2.4 Non-Blocking Know-How License to EOS . Subject to the terms and conditions of this Agreement, Advenchen hereby grants, and shall cause its Affiliates to grant, EOS and its Affiliates a non-exclusive, royalty-free license, with the right to sublicense as provided in Section 2.1(b), the processes and intermediates listed in Exhibit F for the purpose of exercising the rights under Section 2.1.”

(f) Section 8.2 . Section 8.2(a) of the Agreement is hereby amended in full to read as follows:

“8.2 Development Milestone Payments.

(a) Payment Terms . EOS or its applicable sublicensees shall make milestone payments to Advenchen based on achievement of certain milestone events for the Product as set forth in this Section 8.2, in partial consideration for the prior cost of developing the Product. EOS or its applicable sublicensees shall pay to Advenchen the amounts set forth below within *** (***) days after receipt of Advenchen’s invoice following the achievement of the corresponding milestone event; provided , however , that with respect to the payments due under Sections (v), (vii) and (viii) below, EOS or its applicable sublicensee shall not be obligated to make the payment until the procedure set forth in Section 8.2(b) is completed. Each milestone payment by EOS or its applicable sublicensees to Advenchen hereunder shall be payable only once, regardless of the number of times achieved by the Products, and shall not be cumulative. Within fourteen (14) days of the occurrence of each milestone event, EOS or its applicable sublicensee shall provide written notice thereof to Advenchen.

 

Milestone Event

  

Milestone Payment

(i)

 

Upon ***

   $***USD

(ii)

 

Upon ***. For purposes of this milestone event, ***.

  

$***USD,

plus any Notional
Amount

(iii)

 

Upon***.

  

$***USD,

plus any Notional
Amount

(iv)

 

Upon ***.

  

$***USD,

plus any Notional
Amount

(v)

 

Upon ***.

  

$*** USD
(subject to
Section 8.2(b)),

plus any Notional
Amount

(vi)

 

Upon ***.

   $***USD

(vii)

 

Upon ***.

   $*** USD
(subject to
Section 8.2(b))

(viii)

 

Upon ***.

   $*** USD
(subject to
Section 8.2(b))

 

3


(g) Section 8.5(b) . Section 8.5(b) of the Agreement is hereby amended in full to read as follows:

“(b) Removal of Milestone Payments or Sublicense Revenue Payments . Notwithstanding the provisions of Sections 8.2, 8.3 and 8.5(a), upon the execution date (the “ Sublicense Date ”) of an agreement between EOS and a Commercialization Sublicensee, Section 8.5(a) above shall entirely replace all the milestone payments to be made by EOS to Advenchen under Sections 8.2 and 8.3 which have not yet become due as of the Sublicense Date and EOS shall only be required to pay to Advenchen the applicable percentage of the Sublicense Revenue in accordance with Section 8.5(a). Accordingly, on and after the Sublicense Date, (i) EOS shall have no obligation to provide any additional payments to Advenchen under Section 8.2 or 8.3 of this Agreement and all of the terms under Sections 8.2 and 8.3 shall have no further force or effect, and (ii) Advenchen, on its behalf and on behalf of each of its Affiliates, will expressly waive any and all rights to receive any milestone that may become due under Sections 8.2 and 8.3 after the date of such agreement instead receive the corresponding percentage sublicense revenue under Section 8.5(a) from EOS. Within 45 days after the Sublicense Date, EOS shall pay to Advenchen any unpaid Notional Amount after which it shall be deemed to have been paid in full. Within 30 days after the end of each of June and December from each commencing date, EOS shall pay to Advenchen any unpaid Notional Amount (which amounts are non-refundable and not deductible from any other payment required hereby).”

(h) Section 8.6 . Section 8.6 of the Agreement is hereby deleted in its entirety and replaced by “Intentionally Left Blank”.

(i) Article 15 . Article 15 is hereby amended as follows:

(i) Section 15.1 Right of First Negotiation . Section 15.1 is hereby amended as follows:

Section 15.1 is amended by adding the following sentence to the end thereof:

“Upon request by EOS made not more frequently than twice in any 12 month-period, Advenchen will provide EOS with any additional information it has developed with respect to the Expanded Field Assets; provided, that, such information is within Advenchen’s Control and possession and was not received from a licensee or subject to a confidentiality agreement.”

 

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(iii) E List 1 Product Sales. A new Section is hereby added to the end of Article 15 as follows:

15.5 E List 1 Product Sales. If the introduction or sales of one or more E List 1 Products reduce by ***% or more sales by EOS or its sublicensees of a Product, then Advenchen shall pay to EOS***% of future royalties received by Advenchen or its Affiliates with respect to such E List 1 Products. In any dispute regarding this Section 15.5, EOS shall have the burden of proof of demonstrating such reduction in sales.”

ARTICLE 3

AUTHORIZATIONS; CONDITIONS

SECTION 3.01 Due Authorization, Etc. . The execution, delivery and performance of this Amendment have been duly authorized by all necessary action on the part of, and duly executed and delivered by each of the Parties, and this Amendment is a legal, valid and binding obligation of each of the Parties enforceable against any Party in accordance with its terms, except as the enforcement thereof may be subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally and general principles of equity (regardless of whether such enforcement is sought in a proceeding in equity or at law).

SECTION 3.02 Conditions Precedent to Effectiveness of Amendment . This Amendment shall become effective as of the Amendment Effective Date.

SECTION 3.03 Execution in Counterparts . This Amendment may be executed in counterparts, each of which when so executed and delivered shall be deemed to be an original and all of which taken together shall constitute but one and the same instrument.

SECTION 3.04 GOVERNING LAW . THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUCTED AND INTERPRETED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF CALIFORNIA, WITHOUT REGARD TO THE INTERNAL CONFLICTS OF LAWS PROVISIONS THEREOF.

SECTION 3.05 Effect of Amendment . The Parties hereto agree and acknowledge that (i) nothing contained in this Amendment in any manner or respect limits or terminates any of the provisions of the Agreement other than as expressly set forth herein and (ii) the Agreement (as amended hereby) remains and continues in full force and effect and is hereby ratified and reaffirmed in all respects. Upon the effectiveness of this Amendment, each reference in the Agreement to “this Agreement”, “hereunder”, “hereof”, “herein” or words of similar import shall mean and be a reference to the Agreement as amended hereby.

SECTION 3.06 Headings . Section headings in this Amendment are included herein for convenience of any reference only and shall not constitute a part of this Amendment for any other purposes.

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered as of the date first above written.

 

5


ETHICAL ONCOLOGY SCIENCE, S.P.A.
By:  

/s/ Silvano Spinelli

Name:   Dr. Silvano Spinelli
Title:   Chief Executive Officer
ADVENCHEN LABORATORIES LLC
By:  

/s/ Paul Chen

Name:   Dr. Paul Chen
Title:   Chief Executive Officer

 

6


EXHIBIT E

E XCLUDING P ATENTS

L IST 1

 

Application No.

 

Patent

No.

 

Country

 

File Date

 

Issue

Date

***

    ***   ***  

***

    ***   ***  

***

    ***   ***  

***

    ***   ***  

LIST 2

 

Application No.

 

Patent

No.

 

Country

 

File Date

 

Issue

Date

***

    ***   ***  

***

    ***   ***  

***

    ***   ***  

 

7


EXHIBIT F

1. Method of producing the Compound by use of following chemistry process:

***

2. An intermediate compound according to the method 1 above that is selected from the group consisting of:

***

 

8


SECOND AMENDMENT

Second Amendment, dated as of July 30, 2012 (the “ Amendment Effective Date ”) (this “ Amendment ”), to the Development and Commercialization Agreement entered into as of October 24, 2008, as amended by the First Amendment thereto, dated as of April 13, 2010 (the “ Agreement ”) between Advenchen Laboratories LLC (“ Advenchen ”) and Ethical Oncology Science S.P.A. (“ EOS ”).

RECITALS

WHEREAS, EOS and Advenchen are parties to the Agreement; and

WHEREAS, Advenchen and EOS wish to amend the Agreement in certain respects.

NOW, THEREFORE, in consideration of the foregoing and for good and valuable consideration EOS and Advenchen agree as follows:

ARTICLE 1

DEFINED TERMS

SECTION 1.01 Capitalized Terms . Capitalized terms not otherwise defined in this Amendment shall have the meanings ascribed thereto in the Agreement.

ARTICLE 2

AMENDMENTS TO AGREEMENT

SECTION 2.01 Amendments . The Agreement is hereby amended as follows:

(a) Subsequent Filing . Article I of the Agreement is hereby amended by adding the following definition of Subsequent Filing:

“1.79 “ Subsequent Filing ” means a filing by EOS or any of its controlled affiliates (it being understood that neither Advenchen nor any of its controlled affiliates shall be affiliates of EOS) after the Amendment Effective Date of any U.S. IND. or US. Clinical trial application for the Product submitted to the U.S. FDA.”


(b) Section 8.1 of the Agreement is hereby amended by changing the caption thereof to read “Upfront Fees/Second Amendment Fees” and adding the following after the last sentence thereof:

“EOS shall pay Advenchen (i) $*** no later than***, (ii) $*** by no later than *** and (iii) $*** by no later than***. The payments referred to in subclauses (i) through (iii) are referred to herein as the “Second Amendment Fees.” EOS agrees that its failure to make a payment of a Second Amendment Fee when due shall be deemed to be a material breach of this Agreement.” EOS agrees that payment of the Second Amendment Fees shall not be considered a milestone payment offset hereunder for the purposes of the definition of Sublicense Revenue.

(c) Section 8.2 (a) (i) and Section 8.2 (a) (ii) . Sections 8.2 (a) (i) and (ii) are hereby amended in full to read as follows:

 

“(i)

 

Upon the Subsequent Filing for the Product in the Field.

   $*** USD

(ii)

 

Upon ***. For purposes of this milestone event, ***. For the avoidance of doubt, *** will trigger this milestone.

  

$*** USD,

plus any Notional Amount”

(d) Section 8.5 . Section 8.5 of the Agreement is hereby amended in full to read as follows:

“8.5 Sublicense Revenue .

(a) Payment Rates . Subject to the terms of Section 8.5(b), in the event that EOS grants a sublicense to a Third Party under Section 2.1(b), EOS shall pay Advenchen a portion of any Sublicense Revenues received by EOS under each applicable sublicense as set forth below:

(i) Subject to the provisions of the proviso to subclause (ii) below, in the event that the applicable sublicense is executed on or before the date of completion of the first Phase 2 Clinical Trial for the Product in the Field by EOS or any of its controlled affiliates (it being understood that neither Advenchen nor any of its controlled affiliates shall be affiliates of EOS), EOS shall pay Advenchen *** percent (*** %) of the Sublicense Revenue received from the applicable sublicensee; or

(ii) In the event that the applicable sublicense is executed after the date of completion of the first Phase 2 Clinical Trial for the Product in the Field by EOS or any of its controlled affiliates (it being understood that neither Advenchen nor any of its controlled affiliates shall be affiliates of EOS), EOS shall pay Advenchen *** percent (***) of the Sublicense Revenue received from the applicable sublicensee; provided , that , if EOS pays, at EOS’ sole discretion, Advenchen, on or prior to ***, an additional payment of $*** , (which payment shall not be considered a milestone payment offset hereunder for the purposes of the definition of Sublicense Revenue), then only this subclause (ii) shall be applicable to any Sublicense Revenues covered by this Section 8.5.

 

2


(iii) Subject to the terms of Section 9.1, for the avoidance of doubt, all payments to Advenchen under this Section 8.5(a) (if any) shall only become due and payable upon EOS’s actual receipt of the Sublicense Revenue from the applicable sublicensee.”

(b) Removal of Milestone Payments or Sublicense Revenue Payments . Notwithstanding the provisions of Sections 8.2 and 8.3, upon the execution date (the “ Sublicense Date ”) of an agreement between EOS and a Commercialization Sublicensee, Section 8.5(a) above shall entirely replace all the milestone payments to be made by EOS to Advenchen under Sections 8.2 and 8.3 which have not yet become due as of the Sublicense Date and EOS shall only be required to pay to Advenchen the applicable percentage of the Sublicense Revenue in accordance with Section 8.5(a). Accordingly, on and after the Sublicense Date, (i) EOS shall have no obligation to provide any additional payments to Advenchen under Section 8.2 or 8.3 of this Agreement and all of the terms under Sections 8.2 and 8.3 shall have no further force or effect, and (ii) Advenchen, on its behalf and on behalf of each of its Affiliates, will expressly waive any and all rights to receive any milestone that may become due under Sections 8.2 and 8.3 after the date of such agreement instead receive the corresponding percentage sublicense revenue under Section 8.5(a) from EOS, except only as provided in the next sentence with respect to Section 8.2 (i). Within *** days after the Sublicense Date, EOS shall pay to Advenchen any unpaid Notional Amount after which it shall be deemed to have been paid in full and shall pay the milestone specified in Section 8.2 (i) if not paid prior thereto. Within *** days after the end of each of June and December from each commencing date, EOS shall pay to Advenchen any unpaid Notional Amount (which amounts are non-refundable and not deductible from any other payment required hereby).”

ARTICLE 3

AUTHORIZATIONS; CONDITIONS

SECTION 3.01 Due Authorization, Etc . . The execution, delivery and performance of this Amendment have been duly authorized by all necessary action on the part of, and duly executed and delivered by each of the Parties, and this Amendment is a legal, valid and binding obligation of each of the Parties enforceable against any Party in accordance with its terms, except as the enforcement thereof may be subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally and general principles of equity (regardless of whether such enforcement is sought in a proceeding in equity or at law).

SECTION 3.02 Conditions Precedent to Effectiveness of Amendment . This Amendment shall become effective as of the Amendment Effective Date.

SECTION 3.03 Execution in Counterparts . This Amendment may be executed in counterparts, each of which when so executed and delivered shall be deemed to be an original and all of which taken together shall constitute but one and the same instrument.

 

3


SECTION 3.04 GOVERNING LAW . THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUCTED AND INTERPRETED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF CALIFORNIA, WITHOUT REGARD TO THE INTERNAL CONFLICTS OF LAWS PROVISIONS THEREOF.

SECTION 3.05 Effect of Amendment . The Parties hereto agree and acknowledge that (i) nothing contained in this Amendment in any manner or respect limits or terminates any of the provisions of the Agreement other than as expressly set forth herein and (ii) the Agreement (as amended hereby) remains and continues in full force and effect and is hereby ratified and reaffirmed in all respects. Upon the effectiveness of this Amendment, each reference in the Agreement to “this Agreement”, “hereunder”, “hereof”, “herein” or words of similar import shall mean and be a reference to the Agreement as amended hereby.

SECTION 3.06 Headings . Section headings in this Amendment are included herein for convenience of any reference only and shall not constitute a part of this Amendment for any other purposes.

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered as of the date first above written.

 

ETHICAL ONCOLOGY SCIENCE, S.P.A.
By:  

/s/ Silvano Spinelli

Name:   Dr. Silvano Spinelli
Title:   Chief Executive Officer
ADVENCHEN LABORATORIES LLC
By:  

/s/ Paul Chen

Name:   Dr. Paul Chen
Title:   Chief Executive Officer

 

4

Exhibit 10.2

COLLABORATION AND LICENSE AGREEMENT

T HIS C OLLABORATION AND L ICENSE A GREEMENT (the “ Agreement ”) is made and entered into as of September 28, 2012 (the “ Effective Date ”) by and between Ethical Oncology Science S.P.A. , a company incorporated under the laws of Italy, with registered offices at Via Monte di Pietá, 1/A, 20121 Milan, Italy (“ EOS ”) on the first part, and Les Laboratoires Servier , a corporation organized and existing under the laws of France, having offices at 50 rue Carnot, 92284 Suresnes, France and Institut de Recherches Internationales Servier , a corporation organized and existing under the laws of France, having offices at 50 rue Carnot, 92184 Suresnes cedex, France (these two entities jointly referred to as “ Servier ”) on the second part. EOS and Servier are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

R ECITALS :

WHEREAS , Servier is a pharmaceutical company committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human medicine.

WHEREAS , pursuant to the Development and Commercialization Agreement entered into on October 24, 2008 between EOS and Advenchen Laboratories, LLC, as amended on April 13, 2010 and July 30, 2012 (collectively the “ Advenchen Agreement ”), EOS has been granted an exclusive license to develop certain products incorporating a proprietary small molecule protein designated as E-3810.

WHEREAS , Servier and EOS desire to establish a collaboration for the continued development, regulatory approval and commercialization of products containing E-3810, with EOS retaining certain exclusive development and commercialization rights in the U.S. and in Japan, and Servier having exclusive development and commercialization rights in the rest of the world except for the People’s Republic of China, in accordance with the terms and conditions set forth herein.

N OW , T HEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

 

1. D EFINITIONS

Capitalized terms used in this Agreement (other than the headings of the Sections or Articles) have the following meanings set forth in this Article 1, or, if not listed in this Article 1, the meanings as designated in the text of this Agreement.

1.1 “ADBK Actions” each of the actions specified on Schedule 7.4 (c) hereof.

1.2 “Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of the definition in this Section 1.2, the word “ control ” (including, with


correlative meaning, the terms “ controlled by ” or “ under the common control with ”) means the actual power, either directly or indirectly through one (1) or more intermediaries, to direct or cause the direction of the management and policies of such entity either by the ownership of at least fifty percent (50%) of the voting stock of such entity or the ability to otherwise control the management of the corporation.

1.3 “Alliance Manager” has the meaning set forth in Section 2.6.

1.4 Bankruptcy Code has the meaning set forth in Section 15.2.

1.5 Best Knowledge means, as applied to a Party, that the applicable Party’s senior management with operational responsibility for the Development or Commercialization of the Product is actually aware of a particular fact or other matter following reasonable inquiry of its management employees who have the primary responsibility for the applicable subject matter.

1.6 Claims has the meaning set forth in Section 13.1

1.7 Clinical Supply Agreement ” has the meaning set forth in Section 6.3.

1.8 Clinical Trial ” means any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of the Product, and/or to identify any adverse reactions to the Product, and/or to study absorption, distribution, metabolism, and excretion of the Product with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

1.9 Clinical Trial Approval ” means the Regulatory Approval required from the Regulatory Authority in any given country of the European Union to initiate a Clinical Trial in such country, pursuant to Directive 2001/20/EC or any enabling Laws.

1.10 CMC Activities means the Manufacturing and other activities necessary or useful for generating the CMC Information required for Regulatory Approval of the Product, including Manufacture of validation and/or clinical trial materials that are necessary or useful to obtain or maintain Regulatory Approval of a Product.

1.11 “CMC Costs” means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC Activities pursuant to the Manufacturing Plan, including (a) Manufacturing Costs related to Product used in non-clinical and clinical studies and (b) FTE Costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the Development of Products are considered reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets are directly used for the Development of the Products and set forth in the Manufacturing Plan.

1.12 “CMC Information” means Information related to the chemistry, manufacturing and controls of the Product, as specified by FDA or other applicable Regulatory Authority.

1.13 Collaboration has the meaning set forth in Section 2.1.

 

2


1.14 Combination Product ” has the meaning set forth in Section 1.67.

1.15 “Commercialize” means to promote, market, distribute, sell (and offer for sale or contract to sell), import, export, provide product support for a Product, and interacting with Regulatory Authorities regarding the foregoing, and includes post-approval commitments and pharmacovigilance and Phase IV studies. For clarity, Commercializing and Commercialization have a correlative meaning.

1.16 “Committee” means the JEC, JSC, JDC or any other committee established by the Parties pursuant to Section 2.1, as the case may be.

1.17 “Competing Product” means any pharmaceutical product containing a co-selective inhibitor of FGFR-1 and VEGFR kinase.

1.18 Compound ” means a pharmaceutical composition, in any dosage form or form of administration, that contains the small molecule protein tyrosine kinase inhibitor designated as E-3810, as described on Exhibit 1.18, and its pharmaceutically acceptable salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives.

1.19 “Confidential Information” of a Party means any and all Information of such Party that is disclosed to the other Party under this Agreement, whether in oral, written, graphic, or electronic form. The terms of this Agreement shall be Confidential Information of each Party.

1.20 “Controlled” means, with respect to any compound, material, Information or intellectual property right, that the applicable Party owns or has a license to such compound, material, Information or intellectual property right and has the ability to grant to the other Party access, a license or a sublicense (as applicable) to such compound, material, Information or intellectual property right as provided for herein without violating the terms of any agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such access, license or sublicense. For avoidance of doubt, all Information and intellectual property licensed to EOS under the Advenchen Agreement and related to the EOS Technology or the Product in the Territory shall be deemed Controlled by EOS.

1.21 Cover , Covered or Covering means, with respect to any Product and/or any Compound and a Valid Claim included in EOS Patents, that, in the absence of a license or sublicense under, or ownership of, such Valid Claim, the making, using, offering for sale, selling or importing of such Product and/or such Compound would infringe such Valid Claim as issued or following its issuance.

1.22 “Current Good Manufacturing Practice” or “cGMP” means the then-current standards for the manufacture of pharmaceutical products, pursuant to (a) EC Directive 2003/94 EC of October 8, 2003; (b) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products; (c) the International Conference on Harmonization (ICH) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; and (d) all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing.

 

3


1.23 “Data Exclusivity” means, with respect to any country or other jurisdiction in the Licensed Territory, a market protection, granted by a Regulatory Authority in such country or other jurisdiction, during which Servier, its Affiliates or Sublicensees have the exclusive right to Commercialize the Product in such country or other jurisdiction through a regulatory exclusivity right.

1.24 “Develop” or “Development” means, with respect to a Product, all activities relating to preparing and conducting non-clinical studies and other analyses, clinical studies, and regulatory activities ( e.g., preparation of regulatory applications), including test method development and stability testing, assay development, toxicology, formulation, quality assurance/quality control development, statistical analysis, process development, pharmacokinetic studies, Clinical Trials, regulatory affairs, drug safety surveillance activities prior to Regulatory Approval, and obtaining Regulatory Approvals.

1.25 “Development Budget” has the meaning set forth in Section 3.2(a).

1.26 “Development Costs” means all costs incurred by or on behalf of either Party after the Effective Date that are reasonably and directly allocable to the Development of Products pursuant to any Global Development Plan, Unsponsored Work, or Territory-Specific Work, as the context requires. Development Costs shall include but not be limited to CMC Costs, FTE Costs, out-of-pocket costs actually incurred by each Party, costs of any comparator drug (but not Product) used in clinical studies, ethics committees fees, investigators fees, investigators meetings costs, hospital fees and contract (including clinical) research organization’s fees. Development Costs shall include FTE Costs relating to regulatory activities involving preparation, submission of documents related to, and review of clinical trials with any Governmental Authority.

1.27 “Diligent Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, the reasonable, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances. It is understood and agreed that with respect to the research, development and sale of Compound and/or Product by either Party, such efforts shall be substantially equivalent to those efforts and resources commonly used by such Party for pharmaceutical products owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the Product, the likelihood of regulatory approval given the Regulatory Authority involved, the profitability of the Product including the amounts payable to licensors of patent or other intellectual property rights, alternative products and other relevant factors. Diligent Efforts shall be determined on a market-by-market or country-by-country basis, and indication-by-indication basis, and it is anticipated that the level of efforts required shall be different for different markets and indications and shall change over time, reflecting changes in the status of the Product and markets involved.

1.28 Effective Date” has the meaning set forth in the first paragraph of this Agreement.

 

4


1.29 EMA means the European Medicines Agency or any successor entity.

1.30 “EOS Collaboration Patent(s)” means any Sole Invention Patent(s) owned by EOS or its Affiliates pursuant to Section 9.1.

1.31 “EOS Indemnitees” has the meaning set forth in Section 13.1.

1.32 “EOS Know-How” means all Information and materials that are Controlled by EOS or its Affiliates as of the Effective Date or during the Term and are necessary or useful for the Development, Manufacture or Commercialization of a Product, and including the Know-How identified on Exhibit 1.32 attached hereto.

1.33 “EOS Patents” means any Patent that is Controlled by EOS or its Affiliates as of the Effective Date or during the Term and is necessary or useful for the Development, Manufacture or Commercialization of a Product in the Licensed Territory. The EOS Patents existing as of the Effective Date are listed on Exhibit 1.33 . EOS Patents include the EOS Collaboration Patents and EOS’ rights to any Joint Invention Patents.

1.34 “EOS Technology” means the EOS Patents and EOS Know-How.

1.35 “EU” means the European Union, as its membership may be altered from time to time, and any successor thereto.

1.36 Euros ” or “ ” means the lawful currency of the Eurozone.

1.37 Executive Officers means the Chief Executive Officer of EOS and the Chief Executive Officer of Servier (or their respective designees).

1.38 “FDA” means the United States Food and Drug Administration, and any successor thereto.

1.39 Field means (a) oncology (including the prevention, diagnosis, and treatment of tumors), (b) hemathological malignancies, myelodisplasia and myeloproliferative disorders and the prevention, diagnosis, and treatment of the same, and (c), if EOS obtains from Advenchen a license with respect to the Product in the Licensed Territory in any other human or animal therapeutic (including prevention and treatment) or diagnostic applications, all such applications, provided that if extending the Field to any additional application under subclause (c) requires that EOS shall make a payment to Advenchen and/or incur a cost or an obligation, then the Field shall not be extended to any such additional application unless Servier agrees to make such payment and/or pay such cost or discharge such obligation.

1.40 “First Commercial Sale” means, with respect to a Product in a particular country, the first commercial sale of such Product in such country after all necessary Regulatory Approvals have been obtained in such country. Sale of a Product by Servier to an Affiliate or a sublicensee shall not constitute a First Commercial Sale unless such Product is thereafter sold by such Affiliate or sublicensee to the end user of the Product; in addition, in no event shall any sales of Product solely for pre-marketing, testing, or sampling be deemed a First Commercial Sale.

 

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1.41 “FTE” means a full time equivalent of work based on local Laws and practices devoted to or in support of the Development or Manufacture of the Product in accordance with the Global Development Plan or pursuant to this Agreement, that is carried out by one or more qualified scientific or technical employees or contract personnel of EOS or its Affiliates, or Servier or its Affiliates, as measured in accordance with the relevant Party’s normal time allocation practices. For the avoidance of doubt, employees who work fewer than such full time equivalent of work (whether via working a partial year or part-time) are included in an FTE, provided their hours are combined so as to complete one FTE. By way of example, but not limitation, if the full time equivalent of work based on local Laws and practices is one thousand eight hundred (1,800) hours, an employee working one thousand (1,000) hours in a given calendar year would be combined with an employee working eight hundred (800) hours in the same calendar year to form one FTE. Similarly, in such example, any employee can be allocated at a percentage of time equaling less than one hundred percent (100%) of their work calendar year, provided that FTEs are calculated in one thousand eight hundred (1,800) hour increments.

1.42 “FTE Cost” means, for any period, the FTE Rate multiplied by the number of FTEs in such period.

1.43 “FTE Rate” means the rate set forth in Exhibit 1.43  per Calendar Year (pro-rated for the period beginning on the Effective Date and ending at the end of the first Calendar Year). The FTE Rate is “fully burdened” and will cover employee salaries and such facilities and equipment and other materials and services including ordinary laboratory and manufacturing consumables procured from distributors of relevant products as they may use.

1.44 “GAAP” means the international financial reporting standards (“ IFRS ”) as they exist from time to time, or any other generally accepted accounting principles applicable to a Party pursuant to applicable laws.

1.45 “Generic Product means, on a country-by-country and Product-by-Product basis, any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or permitted sublicensee of Servier under a Regulatory Approval granted by a Regulatory Authority to such Third Party, (b) contains the identical or substantially similar active ingredient(s) as an approved Product, and (c) is labeled, advertised, marketed, promoted or intended for use in the Field in such country for an indication that is also an indication for which the Product is labeled, advertised, marketed, promoted or intended for use in such country.

1.46 “Global Development Plan” has the meaning set forth in Section 3.2(a).

1.47 “Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.48 Indemnified Party has the meaning set forth in Section 13.3.

1.49 Indemnifying Party has the meaning set forth in Section 13.3.

 

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1.50 Indication ” means a discrete clinically recognized form of a disease or any precursor condition thereof defined histologically or biologically. For the avoidance of doubt, the treatment and prevention of separate varieties of the same disease or precursor condition shall not be a separate Indication; the treatment or prevention of the same disease or medical condition in a different population shall not be a separate Indication ( e.g. , adult and pediatric); and, for purposes of this Agreement, different forms of breast cancer and of lung cancer respectively which, based on the EMA’s scientific opinion, will be treated as a different indication in the relevant Marketing Authorization shall be regarded as a separate Indication.

1.51 “Information” means all information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.

1.52 “Joint Executive Committee” or “JEC” has the meaning set forth in Section 2.2(a).

1.53 “Joint Inventions” has the meaning set forth in Section 9.1.

1.54 “Joint Invention Patents” has the meaning set forth in Section 9.1.

1.55 “Joint Development Committee” or “JDC” has the meaning set forth in Section 2.4(a).

1.56 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.3(a).

1.57 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.58 “Licensed Territory” means all countries in the world other than (a) the People’s Republic of China and (b) the Retained Territory. For purposes of this Agreement, Servier’s territory shall refer to the Licensed Territory and EOS’ territory shall refer to the Retained Territory.

1.59 Liens has the meaning set forth in Section 9.7.

1.60 Litigation Conditions ” has the meaning set forth in Section 13.3.

1.61 MAA Filing means validation by the EMA of the filing of a Marketing Authorization Application for the applicable Product under the centralized European procedure, as demonstrated by the start of the procedure under the timetable adopted by the Committee for Medicinal Products for Human Use (CHMP) or any successor thereof.

1.62 “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, inspection, receiving, holding and shipping of Compound, Products, or any raw materials or packaging materials with respect thereto, or any

 

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intermediate of any of the foregoing, including process and cost optimization, process development, qualification and validation, equipment and facility qualification and validation, commercial manufacture, stability and release testing, quality assurance and quality control. For clarity, Manufacture and Manufactured have correlative meanings.

1.63 “Manufacturing Costs” means with respect to either Party, ***% of the actual, fully-burdened cost of all Manufacturing activities, including raw materials, direct labor and benefits, and the proportionate share (as determined pursuant to the subsequent sentence) of indirect manufacturing costs, including third party manufacturing costs. For clarity, such fully-burdened cost shall be calculated (i) on a theoretical full-capacity basis (with reasonable deductions for changeover and maintenance downtime) with the percentage allocable to Manufacturing Costs representing the number of units or runs of Product produced or performed as a percentage of the total number of units or runs, including those of other products, that could be manufactured in such facility during a calendar year and (ii) in accordance with GAAP, consistently applied. Costs that cannot be identified to a specific activity supporting product manufacturing, such as charges for central corporate overhead that are not controllable by the manufacturing plant, shall not be included in the determination of Manufacturing Costs. For avoidance of doubt, Manufacturing Costs do not include any margin or mark-up relating to inter-company supply between the manufacturing Party and its Affiliates (or among such Affiliates).

1.64 “Manufacturing Transfer” has the meaning set forth in Section 6.1.

1.65 “Manufacturing Plan” has the meaning set forth in Section 6.2.

1.66 “Marketing Authorization Application” or “ MAA ” means: (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in any country in the European Union if the centralized EMA filing procedure is not used to obtain Regulatory Approval to market or sell; or (b) any other equivalent or related Regulatory Submission to gain approval to market a Product in any country in the Licensed Territory. Marketing Authorization or “ MA ” means the approval of the MAA by the relevant Regulatory Authority.

1.67 “Net Sales” means with respect to a particular time period during the Royalty Term, the total amounts invoiced by Servier, its Affiliates and their respective sublicensees for sales of Products made during such time period to unaffiliated Third Parties, less the following deductions (on an accrual basis) in each case to the extent reasonable and customary actually allowed or incurred, and included in the invoiced price of the Product or otherwise documented, with respect to such sales:

(a) discounts, including cash and quantity discounts (including early payment discounts), charge-back payments, and rebates actually granted or administrative fees actually paid to: trade customers; patients (including those in the form of a coupon or voucher); managed health care entities; drug benefit managers; group purchasing organizations; federal, state, or local government (including those for governmental, regulatory or agency mandated rebate programs); the agencies, purchasers and reimbursers of managed health care entities; and drug benefit managers;

 

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(b) credits or allowances actually granted upon prompt payment or claims, damaged goods, rejections or returns of such Product, including in connection with recalls;

(c) freight, postage, shipping, transportation and insurance charges, in each case actually allowed or paid for delivery of Product, to the extent billed or recognized;

(d) taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of such Product, including, value-added and sales taxes;

(e) amounts actually paid to Third Party distributors solely for and in respect of the sale of Product;

(f) the actual amount of any write-offs for bad debt; provided with respect to such write-off that an amount subsequently recovered or reversed with respect to such write-off will be treated as Net Sales in the quarter in which it is recovered or reversed. Servier will use Diligent Efforts to minimize bad debts; and

(g) any other specifically identifiable amounts included in gross amounts invoiced for Products, to the extent such amounts are customary deductions from net sales calculations in the pharmaceutical or biotechnology industries in the applicable country or countries in the Licensed Territory related to non-Affiliates for reasons substantially equivalent to those listed above and are reasonable in an amount relative to similar deductions taken by Servier or its applicable sublicensee in calculating net sales of their other products.

Notwithstanding the foregoing, amounts invoiced by Servier, its Affiliates, or their sublicensees for the sale of Product among Servier, its Affiliates or their respective sublicensees for resale shall not be included in the computation of Net Sales hereunder and such amounts shall be accounted for only once. For purposes of determining Net Sales, a “sale” shall not include reasonable transfers or dispositions, at no cost, as samples or for charitable purposes, or transfers or dispositions at no cost for Non-Clinical Studies, clinical or regulatory purposes. Net Sales shall be accounted for in accordance with GAAP consistently applied in such country in the Licensed Territory.

In the event the Product is sold in a finished dosage form containing the Compound in combination with one or more other active ingredients (a “ Combination Product ”), the Net Sales of the Product, for the purposes of this Agreement, shall be determined by multiplying the Net Sales (as defined above) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. In the event that such average sale price cannot be determined for both the Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be agreed by the Parties in good faith based on the relative value contributed by each component.

1.68 Non-Arbitrable Dispute shall have the meaning in Section 14.3.

 

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1.69 “Patent” means all: (a) unexpired letters patent (including inventor’s certificates) which have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period (and which have not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or been abandoned in accordance with or as permitted by the terms of this Agreement or by mutual written agreement), including any substitution, extension, registration, confirmation, reissue, re-examination, supplementary protection certificates, confirmation patents, patent of additions, renewal or any like filing thereof; (b) pending applications for letters patent which have not been canceled, withdrawn from consideration, finally determined to be unallowable by the applicable governmental authority or court for whatever reason (and from which no appeal is or can be taken), and/or abandoned in accordance with or as permitted by the terms of this Agreement or by mutual written consent, including any continuation, division or continuation-in-part thereof and any provisional applications; and (c) any international counterparts to (a) and (b) above.

1.70 “Phase 3 Clinical Trial(s)” means a human clinical trial of a Product on patients that is designed to establish that such Product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with such Product in the dosage range to be prescribed, and to support Regulatory Approval of such Product or label expansion of such Product. 

1.71 Pivotal Clinical Trial means a human clinical trial of the Product on a sufficient number of subjects that satisfies both of the following:

(a) such trial provides adequate basis for assessing the benefit/risk of the Product to support an MAA Filing; and

(b) such trial is sufficient for a MAA Filing according to the EMA’s scientific advice.

1.72 Product means any pharmaceutical composition, in any dosage form, formulation, improvement or mode of administration that comprises or incorporates the Compound.

1.73 “Product Infringement” has the meaning set forth in Section 9.4(a).

1.74 “Product Marks” has the meaning set forth in Section 5.3.

1.75 Quality Agreement has the meaning set forth in Section 6.3.

1.76 “Regulatory Approval” means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the EU), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use or sale of a Product in a regulatory jurisdiction.

1.77 “Regulatory Authority” means the applicable national (e.g., the FDA), supra-national (e.g., the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity that, in each case, governs the Regulatory Approval of a Product in such applicable regulatory jurisdiction.

 

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1.78 “Regulatory Materials” means regulatory applications, submissions, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or useful in order to Develop, Manufacture, market, sell or otherwise Commercialize a Product in a particular country or regulatory jurisdiction.

1.79 “Retained Territory” means (a) the U.S. and (b) Japan, in each case including its territories and possessions.

1.80 “Retained Territory License Agreement” has the meaning set forth in Section 3.1(b).

1.81 “Royalty Term” has the meaning set forth in Section 8.5(b).

1.82 Safety Data Exchange Agreement ” has the meaning set forth in Section 4.6.

1.83 “Servier Indemnitees” has the meaning set forth in Section 13.2.

1.84 “Sole Inventions” has the meaning set forth in Section 9.1.

1.85 “Sole Invention Patents” has the meaning set forth in Section 9.1.

1.86 “Term” has the meaning set forth in Section 11.1.

1.87 “Territory-Specific Work” means any clinical or non-clinical study performed by a Party solely in its respective territory and that is required only by Regulatory Authorities in that Party’s territory in order to obtain or maintain Regulatory Approval for the Product, and not by the Regulatory Authorities in the other Party’s territory.

1.88 “Third Party” means any person or entity other than: (a) EOS; (b) Servier; or (c) an Affiliate of either Party.

1.89 “Third Party Partner” has the definition set forth in Section 3.1(b).

1.90 Unsponsored Work has the meaning set forth in Section 3.5(b).

1.91 U.S. means the United States of America, including all possessions and territories thereof.

1.92 Valid Claim means any claim of (a) any issued and unexpired patents in the Licensed Territory that has not been (i) revoked or held unenforceable, unpatentable or invalid by a Government Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal or (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or

 

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otherwise, or (b) any patent application that has not been (i) cancelled, withdrawn or abandoned without being refiled in another application in the applicable jurisdiction or (ii) finally rejected by an administrative agency or Government Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal, provided that, on a country-by-country basis, a patent application pending for more than five (5) years from the later of the priority or filing date of such application shall not be considered to have any Valid Claim for purposes of this Agreement from and after such five (5) year date, unless refiled as provided in (b)(i) above.

 

2. C OLLABORATION ; C OMMITTEES

2.1 Collaboration Overview. The Parties desire and intend to collaborate with respect to the Development of the Product, with EOS retaining rights to the Product with respect to the Retained Territory, and Servier being granted exclusive rights to the Product with respect the Field in the Licensed Territory (the “ Collaboration ”). The Parties shall establish the committees as described in this Article 2 and may from time-to-time establish other committees or sub-committees to report to the Joint Steering Committee in order to effectively implement the Collaboration as jointly agreed by the Parties.

2.2 Joint Executive Committee .

(a) Establishment. Within thirty (30) days after the Effective Date, the Parties shall establish a joint executive committee (the “ Joint Executive Committee ” or “ JEC ”), all in accordance with this Section 2.2. The JEC membership and procedures are further described in Section 2.8.

(b) Specific Responsibilities of the JEC. The JEC shall in particular, in accordance with the decision-making principles set forth in Section 2.8, manage the overall Collaboration (including but not limited to major changes to the Collaboration requiring amendments to the Agreement) and resolve any disputed matter of the JSC.

2.3 Joint Steering Committee .

(a) Establishment. Within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “ Joint Steering Committee ” or “ JSC ”) to monitor and oversee their activities under this Agreement, all in accordance with this Section 2.3. The JSC membership and procedures are further described in Section 2.7.

(b) Specific Responsibilities of the JSC. The JSC shall in particular, in accordance with the decision-making principles set forth in Section 2.8:

(i) coordinate the activities of the Parties under this Agreement, including facilitating communications between the Parties with respect to the Development and Manufacture of the Product;

(ii) provide a forum for discussion of the Development and Manufacture of the Product;

 

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(iii) review and approve the Global Development Plan and associated Development Budgets and any annual or interim updates and proposed amendments thereto;

(iv) review and approve the Manufacturing Plan and associated budget and any annual or interim updates and proposed amendments thereto;

(v) attempt to resolve issues presented to it by, and disputes within, the other Committees in accordance with Section 2.8; and

(vi) perform such other duties as are expressly assigned to the JSC in this Agreement, and perform such other functions as appropriate to further the purposes of this Agreement as may be allocated to it by written agreement of the Parties.

2.4 Joint Development Committee .

(a) Establishment. Within thirty (30) days after the Effective Date, the Parties shall establish a joint development committee (the “ Joint Development Committee ” or “ JDC ”) to monitor and coordinate the Development of Products under this Agreement. The JDC membership and procedures are further described in Section 2.7.

(b) Specific Responsibilities of the JDC.  The JDC shall in particular, in accordance with the decision-making principles set forth in Section 2.8:

(i) coordinate the activities of the Parties under and oversee the implementation of the Global Development Plan agreed to by the Parties;

(ii) prepare annual and interim updates to the Global Development Plan;

(iii) provide a forum for and facilitate communications between the Parties with respect to the Development of the Product, including any additional indications proposed by either Party to be jointly pursued;

(iv) monitor and coordinate all regulatory actions, communications and submissions for Products under each Global Development Plan;

(v) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development of Products, as directed by the JSC ; and

(vi) review proposed Unsponsored Work and Territory-Specific Work.

The JDC shall develop a timetable and plan to transition from EOS to Servier all material aspects of the Development of the Product in the Licensed Territory which will include details of all on-going studies and all clinical trial data (the “ Transition Plan ”).

 

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2.5 Program Director. Within thirty (30) days after the Effective Date, each Party shall appoint and notify the other Party of the identity of a representative to act as its program director under this Agreement (the “ Program Director ”). The Program Directors shall serve as the primary contact points between the Parties for the purpose of providing each Party with information on the progress of each Party’s development and business related activities under this Agreement. The Program Directors shall also be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties. The Program Directors (or their designees for a particular meeting) shall attend all JSC and JDC meetings, and shall have the right to attend all other Committee meetings, and shall support the co-chairpersons of each Committee in the discharge of their responsibilities. A Program Director may also bring any matter in relation to the Development to the attention of any Committee if such Program Director reasonably believes that such matter warrants such attention. Each Party may replace its Program Director at any time upon written notice to the other Party.

2.6 Alliance Manager. Within thirty (30) days after the Effective Date, each Party shall appoint and notify the other Party of the identity of a representative to act as its alliance manager under this Agreement (the “ Alliance Manager ”), provided that Servier may elect to appoint two such representatives, one as business alliance manager and one as R&D alliance manager. The Alliance Managers shall serve as the primary business contact points between the Parties for the purpose of providing each Party with information on the progress of each Party’s business related activities under this Agreement and for any activities not falling within the scope of responsibility of the Program Director. The Alliance Managers shall also be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties. The Alliance Managers (or their designees for a particular meeting) shall attend all JSC and JDC meetings, and shall have the right to attend all other Committee meetings. An Alliance Manager may also bring any matter to the attention of any Committee if such Alliance Manager reasonably believes that such matter warrants such attention. Each Party may replace its Alliance Manager at any time upon written notice to the other Party. The Program Director and Alliance Manager may be the same Person.

2.7 General Committee Membership and Procedures .

(a) Membership. Each of Servier and EOS shall designate representatives to serve as members of each Committee, and each representative may serve on more than one Committee as appropriate. Each Party shall have an equal number of representatives on each Committee (provided that EOS shall be entitled to have fewer members than Servier). Each Party may replace its Committee representatives at any time upon written notice to the other Party. Each Committee shall have co-chairpersons. Servier and EOS shall each select from their representatives a co-chairperson for each of the Committees, and each Party may change its designated co-chairpersons from time to time upon written notice to the other Party. The co-chairpersons of each Committee shall be responsible for calling meetings and preparing and circulating meeting agendas and minutes, but the co-chairpersons shall have no additional powers or rights beyond those held by other Committee members.

(b) Meetings. Each Committee shall hold meetings at such times as it elects to do so, provided that unless the Parties otherwise agree in writing to a different frequency for such meetings, each of the JDC and the JSC shall meet at least three (3) times each calendar year

 

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and the JEC shall meet at least once each calendar year. Either Party may also call a special meeting of a Committee (by videoconference or teleconference) by at least ten (10) business days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next regularly scheduled meeting, and such Party shall provide the applicable Committee no later than ten (10) business days prior to the special meeting with materials reasonably adequate to enable an informed decision at such meeting. No later than ten (10) business days prior to any Committee meeting, the co-chairpersons of such Committee shall prepare and circulate an agenda for such meeting; provided , however , that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. Each Committee may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in its meetings, provided , that , such non-member participants shall have no voting authority at such meetings, and may be excluded by either Party if there is an actual or potential conflict of interest. Each Committee may meet in person, by videoconference or by teleconference, provided , however , at least one (1) meeting of each Committee per calendar year shall be in person unless the Parties mutually agree in writing to waive such requirement. In-person Committee meetings shall be held alternately in Milan, Italy and Paris, France. Each Party shall bear the expense of its respective Committee members’ participation in Committee meetings. Committee meetings shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. The co-chairpersons of a Committee shall be responsible for preparing reasonably detailed written minutes of all meetings of such Committee that reflect all material decisions made at such meetings. The co-chairpersons shall send draft meeting minutes to each member of such Committee for review and approval promptly after each Committee meeting. Such minutes shall be deemed approved unless one or more members of such Committee objects to the accuracy of such minutes within thirty (30) days of receipt by such member.

(c) Scheduling Meetings. The various Committee meetings shall be scheduled on days and places compatible with EOS’ relative size.

2.8 Decision Making .

(a) Within JSC and Operating Committees. All decisions within the JSC, JDC or any other Committee other than the JEC shall be made by consensus, with each Party having collectively one (1) vote. If a dispute arises which cannot be resolved within any Committee other than the JSC and the JEC, the representatives of either Party may cause such dispute to be referred to the JSC for resolution. If after reasonable discussion and good faith consideration of the other Party’s views on a particular matter before the JSC, including any disputes referred to the JSC by another Committee, the JSC is still unable to reach a unanimous decision on such matter for a period of fifteen (15) days, then either Party may cause such dispute to be referred to the JEC for resolution as provided in Section 2.8(b) below.

(b) Within the JEC. Upon being referred a disputed matter from the JSC under Section 2.8(b), or arising within the JSC, the JEC shall consider such matter and discuss it in good faith, and shall strive to seek consensus in its actions and decision making process. If after reasonable discussion and good faith consideration of the other Party’s views on a particular matter before the JEC, including any disputes referred to the JEC by another Committee, the JEC

 

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is still unable after a period of thirty (30) days to reach a unanimous decision on such matter, then either Party may upon notice to the other Party, refer such matter to the Executive Officers of the Parties for attempted resolution by good faith negotiations within thirty (30) days after such notice is received, including at least one (1) in person meeting of the Executive Officers within twenty (20) days after such notice is received. If the Executive Officers are not able to resolve such disputed matter within thirty (60) days and either Party wishes to pursue the matter, then:

(i) Servier shall have the right to decide such dispute if such matter relates to: (A) Development of the Product for Regulatory Approval in the Licensed Territory or Development activities conducted in the Licensed Territory, (B) the Manufacture of Product for use and sale in the Licensed Territory, or (C) the Global Development Plan to the extent that it does not reasonably jeopardize the perspective of obtaining Regulatory Approval for the Product in the Retained Territory; and

(ii) EOS shall have the right to decide such dispute if such matter is not covered in subclause (i) above and relates to: (A) Development of the Product for Regulatory Approval in the Retained Territory or Development activities conducted in the Retained Territory, or (B) the Manufacture of Product for use and sale in the Retained Territory.

(c) Exceptions. Neither Party shall be permitted to use its final decision making authority to impose any obligations or costs on the other Party.

(d) Limitations of Committee Authority. Each Committee shall have solely the powers expressly assigned to it in this Article 2 and elsewhere in this Agreement or as otherwise agreed to by the Parties in writing. A Committee shall not have any power to amend, modify, or waive compliance with the terms of this Agreement. It is expressly understood and agreed that the control of decision-making authority by EOS or Servier, as applicable, pursuant to this Section 2.8, so as to resolve a disagreement or deadlock on a Committee or between the Executive Officers for any matter will not authorize either Party to unilaterally modify or amend, or waive its own compliance with, the terms of this Agreement.

(e) Good Faith. In conducting themselves on Committees, and in exercising their rights under this Section 2.8, all representatives of both Parties shall use reasonable efforts to consider, reasonably and in good faith, all input received from the other Party, and to reach consensus on all matters before them. Notwithstanding anything to the contrary in this Agreement, neither Party nor any of its Affiliates shall be required to take, or shall be penalized for not taking, any action that is not in compliance with such Party’s ethical business practices and policies or that such Party reasonably believes is not in compliance with applicable Laws.

2.9 Discontinuation of Participation on a Committee .

(a) Each Committee, including the JSC and the JEC, shall continue to exist until the first to occur of (i) the Parties mutually agreeing to disband the Committee, or (ii) Servier providing to EOS written notice of its decision to disband and no longer participate in such Committee.

 

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(b) Once the JSC, the JEC or any other Committee is disbanded in accordance with Section 2.9(a), such Committee shall have no further obligations under this Agreement and, thereafter, the Program Directors will be the contact persons for the exchange of information under this Agreement, and decisions of such Committee shall be decisions of the responsible Party as specified in this Agreement, subject to any other terms of this Agreement.

2.10 Compliance with Law. Each Party and its Affiliates shall comply in all material respects with all applicable Laws in the Development, Manufacture, and Commercialization of Products performed under this Agreement.

 

3. D EVELOPMENT OF P RODUCTS

3.1 General .

(a) Overview . Unless otherwise specified in a Global Development Plan or under this Agreement, each Party shall be responsible and have the final decision-making authority for all Development activities conducted in its respective territory.

(b) Third Party Partner. Servier acknowledges and understands that EOS intends to enter into one or more license or partnership agreements with one or more Third Parties under which EOS grants any such Third Party(s) exclusive license rights to Develop and or Commercialize the Products in one or more Indications in some or all of the Retained Territory (each such Third Party, a Third Party Partner and each such agreement, a Retained Territory License Agreement ). In this respect, the Parties agree that (and, in its agreement with any Third Party Partner, EOS shall include obligations at least as protective to Servier as the obligations below and shall be liable vis-à-vis Servier for the compliance by the Third Party Partner of such obligations):

(i) Servier shall consider in good faith such Third Party Partner’s rights to participate in the Committees established under this Agreement, in order to facilitate the effective and efficient communications regarding Development of Products throughout both the Retained Territory and the Licensed Territory, upon terms and conditions to be agreed upon.

(ii) If EOS and/or such Third Party Partner(s) desire to conduct human clinical studies with respect to the Product for use in seeking Regulatory Approval for or Commercializing the Product in the Retained Territory, such studies or trials would be subject to the provisions of Section 3.5. Unless such study falls within the definition of Territory Specific Work, to the extent Servier on the one hand, and EOS and its Third Party Partner, on the other hand, do not agree to pursue jointly any such study as provided in Section 3.5, such study shall be “Unsponsored Work” as provided thereunder. Any data with respect to the Product generated by or on behalf of EOS and/or such Third Party Partner(s) pursuant to Territory Specific Work or Unsponsored Work (the “ Third Party Data ”), shall be available for use by Servier in the Licensed Territory to the extent provided in Section 3.5; and

(iii) EOS shall have the right to disclose to such Third Party Partner all Information regarding Products and all Regulatory Materials generated pursuant to the Global Development Plan for use (including by cross-reference) by the Third Party Partner, in its Development and Commercialization of Products in the Retained Territory, consistent with

 

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Sections 4.4(a) and 4.4(c), and Article 10, provided that such Third Party Partner agrees to disclose to Servier all Information and Regulatory Materials Controlled by such Third Party Partner for use (including by cross-reference) by Servier, subject to Section 3.1(b) (ii), in its Development, Manufacturing and Commercialization of Products in the Licensed Territory and provided that in the Retained Territory License Agreement, the Third Party Licensee shall agree to accept all risk and liability in relation to the use of the Information and Regulatory Materials received from Servier (directly or through EOS) and to indemnify and hold harmless Servier from any Third Party’s claim(s) based upon such Information and Regulatory Materials on terms no less favorable than EOS’ indemnity obligations set forth in Article 13. A redacted copy of the Retained Territory License Agreement containing this provision shall be provided by EOS to Servier upon execution of the Retained Territory License Agreement.

(iv) As between the Parties, the Development, Manufacture and Commercialization of the Product in the Retained Territory by a Third Party Partner shall be deemed to be by EOS for purposes of this Agreement.

3.2 Global Development Plan .

(a) The Development of a Product under this Agreement shall be conducted pursuant to a written development plan, as may be amended pursuant to Section 3.2(d) (the Global Development Plan ), which shall include a detailed budget for all Development activities set forth in such plan ( Development Budget ). The Global Development Plan also shall set forth the specific activities to be conducted by each Party and the estimated timeline for Development of the Product in order to obtain data that the Parties intend will be useful, by both Parties, to obtain Regulatory Approvals of the Product by the FDA and by the European Commission. The Global Development Plan shall also specify the plans and estimated timeline for preparing the necessary Regulatory Materials for obtaining Regulatory Approval in such territories subject to Section 4.1. Pursuant to the Global Development Plan, Servier shall be the sponsor of all clinical studies conducted in the Licensed Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for the Product in the Licensed Territory, and EOS shall be the sponsor of all clinical studies conducted in the Retained Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for the Product in the Retained Territory, provided that if clinical studies pursuant to the Global Development Plan need to be conducted by the same sponsor both in the Licensed Territories and the Retained Territories, then, (a) Servier, in its sole discretion, may elect to sponsor such clinical studies, or (b) if Servier does not so elect, either the Parties shall contract a Third Party clinical organization which will act as the sponsor of such clinical studies, or EOS or its Third Party Partner (if any) shall act as the sponsor of such clinical studies.

(b) Development Costs . Servier shall be responsible for all Development Costs under the Development Budget for the Global Development Plan (the initial version of which is attached hereto as Exhibit 3.2 ), up to a total of Eighty Million Euros (€80,000,000), including the residual cost of the ongoing phase I-IIa study E-3810-I-01 (up to an aggregate amount of Three Million Euros (€3,000,000)) and all CMC Costs for all CMC Activities specified in the Global Development Plan. Any Development Costs (including CMC Costs) incurred in accordance with the Development Budget and the Global Development Plan in excess of the above maximum shall be borne by Servier. Notwithstanding the foregoing, sixty percent (60%) of the

 

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portion of the Development Costs in excess of the Eighty Million Euros (€80,000,000) cap (the “ Reimbursable Amount ”) shall be paid back by EOS to Servier 90 days after the first occurrence of one of the following events; provided, that, EOS shall only be obligated to pay 50% of such costs if it otherwise elects to reimburse Servier for such costs on a current basis as otherwise provided for herein: (i) first filing with the FDA for the new drug application for the Product, (ii) grant by EOS to a Third Party of a license for development and/or marketing of the Product in the U.S., or (iii) change of control, merger, consolidation or sale of substantially or all of the business or assets of EOS. Notwithstanding the preceding sentence, the Reimbursable Amount shall be paid back by EOS to Servier at the latest on the second anniversary of the availability of the final report of the Phase 3 Clinical Trial pursuant to the Global Development Plan, provided that if the Agreement is terminated pursuant to Section 11.2 prior to or during such two-year period, the provisions of Section 11.6 (g) shall apply. Following the events set forth in subclauses (i) through (iii) above, any subsequent Development Costs will be shared equally between the Parties. The Parties shall reconcile their expenses incurred under this Section 3.2(b), all as provided in Section 3.3. For avoidance of doubt, any Development Costs incurred by a Party not in accordance with the Development Budget and the Global Development Plan shall be borne solely by such Party and shall not be subject to reimbursement unless otherwise agreed by the other Party.

(c) Reports. Each Party shall provide the other party and the JDC with regular reports detailing its Development activities and Development Costs under the Global Development Plan and the results of such activities at each regularly scheduled JDC meeting.

(d) Amendments . Beginning with the first full calendar year following the Effective Date, on an annual basis (no later than June 30th), or more often as the JDC deems appropriate, the JDC shall review and, as required, prepare an update and amendment to the Global Development Plan, for approval by the JSC. Each such updated and amended Global Development Plan shall reflect any changes, additions, re-prioritization of studies and/or indications within, and/or reallocation of resources with respect to, the Development of the Product. Once approved by the JSC, an amended Global Development Plan shall become effective and supersede the previous Global Development Plan as of the date of such approval.

3.3 Reconciliation and Reimbursement .

(a) With respect to Development Costs incurred by EOS during a calendar quarter and which are to be reimbursed as provided under Section 3.2(b), such reimbursement shall be done on the basis of documented FTE at the FTE Rates and documented incurred out of pocket material and Third Party services costs comprising such Development Costs (including any CMC Costs), as the case may be. EOS shall invoice Servier for such amounts on a calendar quarterly basis, and Servier shall pay each such invoice within forty five (45) days after receipt thereof.

(b) With respect to Development Costs incurred by the Parties at such time as they are sharing such costs, as provided in Section 3.2(b), within thirty (30) days after the end of each calendar quarter, each Party shall provide the other Party with a detailed, activity-based statement of such Development Costs (the Cost Report ) (or in each case an estimate of any portions thereof where actuals are not known as of such time) as well as details of any adjustments to be made to the amounts submitted in the previous calendar quarter, in a format to

 

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be agreed-upon by the Parties. Within forty-five (45) days after the end of the calendar quarter, Servier shall provide EOS with a written report (the Reconciliation Report ) setting forth in a format to be agreed-upon by the Parties, the calculations of each Party’s share of such Development Costs. Such Reconciliation Report shall include for such calendar quarter the (i) total Development Costs incurred by each Party, and each Party’s respective share thereof, and (ii) the net payment due from one Party to the other Party in accordance with this Section 3.3(b). Any net payment owed from one Party to the other Party shall be paid within sixty (60) days following such reconciliation, provided that if a Party disputes an amount provided in such Reconciliation Report then such disputed amount shall be reviewed by the JDC, and any net payment owed with respect to the undisputed amounts shall be paid within the above set forth timeline. If requested by a Party, any invoices or other supporting documentation for any payments to a Third Party shall be promptly provided.

3.4 Unsponsored Work and Territory-Specific Work. Notwithstanding anything to the contrary in this Agreement except as otherwise provided under Section3.5 (b) below, the costs for all Unsponsored Work and Territory-Specific Work shall be borne solely by the Party undertaking such activities.

3.5 Additional Studies or Indications .

(a) If a Party (including through its Affiliates or sublicensees, including with respect to EOS, any Third Party Partner) intends to conduct one or more additional human clinical studies (beyond what is then included in a applicable Global Development Plan) in the Field for Development of the Product, either in an Indication already covered by the Global Development Plan or in a new Indication, such Party shall notify the other of such proposed studies and provide the other Party of any supporting data or publications supporting any such proposal. In such event, the JDC shall consider such proposal and evaluate the supporting data and Information in good faith. If both Parties’ JDC Representatives agree to conduct such proposed Development, the JDC shall prepare an amendment to the applicable Global Development Plan to include the proposed studies for approval by the JSC.

(b) Subject to Servier’s exclusive right to Develop the Product in the Licensed Territory and EOS’s exclusive right to Develop the Product in the Retained Territory, if the non-proposing Party is not interested in pursuing or funding such additional human clinical studies and, if such studies are not Territory Specific Work, such non-proposing Party does not reasonably object to such additional human clinical studies for likely having a material adverse effect upon the procurement or maintenance of Regulatory Approval or Commercialization of a Licensed Product in its territory then the proposing Party shall have the right to perform the proposed activities (the “ Unsponsored Work ”) at its own expense. The proposing Party shall deliver to the JDC all proposed plans for such Unsponsored Work in advance of commencing such activities and deliver an update on such Unsponsored Work at each meeting of the JDC. Promptly following completion of the Unsponsored Work, the proposing Party shall deliver to the JDC the top-line data summary and shall disclose all other Information resulting from such Unsponsored Work to the other Party pursuant to Section 4.4. Any Indications pursuant to Unsponsored Work done by Servier or on its behalf and not reimbursed by EOS pursuant to the following sentence, shall not be subject to the milestone payments specified under Article 8. If, thereafter, the non-proposing Party wishes to have the right to use the resulting Information, it

 

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may do so upon reimbursing the proposing Party for *** percent (***%) of its Development Costs for such Unsponsored Work. Once the non-proposing Party has reimbursed such amounts, the Information from such Unsponsored Work shall be treated as Information resulting from the Global Development Plan pursuant to this Agreement.

(c) Each Party shall inform the other Party of its intent to conduct one or more human clinical studies falling within the definition of Territory-Specific Work and provide all Information related to such studies as reasonably requested by the other Party except to the extent prohibited by Laws.

(d) Notwithstanding anything to the contrary in this Agreement, each Party shall have access to and the right to use at no cost to such Party all Information resulting from the Unsponsored Work and Territory-Specific Work conducted by or on behalf of the other Party, its Affiliates and its sublicensees as necessary to comply with the regulatory requirements in its territory solely with respect to safety reporting and such Party’s license rights and rights of reference to such Information shall be limited solely to such purpose or to other purposes to the extent that such other purposes are necessary to comply with mandatory regulatory requirements.

3.6 Development Diligence; Standards of Conduct. Each Party shall use Diligent Efforts to Develop the Product and carry out the activities assigned to it under the Global Development Plan. The Parties acknowledge and agree that the Global Development Plan or any other Development activities may consist of consecutive phases or stages and that the determination that the outcome of any given phase or stage is successful may be required or commercially reasonable prior to moving to the subsequent phase or stage.

3.7 Development Records. Each Party shall (and shall cause its sublicensees, or with respect to EOS, any Third Party Partner to) maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it or on its behalf (including by sublicensees and, with respect to EOS, any Third Party Partner) under the Global Development Plan. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Global Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review and receive a copy of such records (including a copy of the databases) maintained by the other Party (including its sublicensees, or with respect to EOS, the Third Party Partner) at reasonable times, but no less than twice in any one calendar year, and to obtain access to source documents to the extent needed for patent or regulatory purposes or for other legal proceedings. The Parties may agree to set up an electronic data room in order to manage the exchange of information in a secure manner.

3.8 Subcontracts . Each Party may perform any of its obligations under this Agreement through one or more subcontractors and consultants and shall provide information in that regard to the JDC, provided that (a) such Party remains responsible for the work allocated to, and payment to, such subcontractors and consultants as it selects to the same extent it would if it had done such work itself; (b) the subcontractors and consultants undertake in writing obligations of confidentiality and non-use regarding Confidential Information that are substantially the same as those undertaken by the Parties pursuant to Article 10 hereof; and (c)

 

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the subcontractors and consultants execute an agreement with present tense assignment language assigning all intellectual property developed in the course of performing any such work under the Global Development Plan to the Party retaining such subcontractors or consultants.

3.9 Personnel . All employees, agents and subcontractors of each Party and its Affiliates conducting activities under this Agreement shall, prior to commencing any such activities, have executed an agreement with present tense assignment language assigning any inventions and related intellectual property rights to the Party by whom they are employed or for whom they are providing services (or its designated Affiliate). The Parties acknowledge and agree that this Agreement shall be deemed to be a joint research agreement under 35 U.S.C. §103(c).

3.10 Development in Retained Territory . Notwithstanding anything to the contrary in this Agreement, and further notwithstanding any pre-clinical or clinical data disclosed by Servier under this Agreement, the Parties agree and acknowledge that Servier shall have no involvement whatsoever in the Development, Commercialization and/or Manufacture of Products in the Retained Territory other than such obligations as are expressly provided herein. Servier shall not be obligated to participate in any activities related to the Development, Commercialization and/or Manufacture of Products in the Retained Territory, nor shall it have any right to do so.

 

4. R EGULATORY M ATTERS

4.1 Responsible Regulatory Party. Unless to the extent otherwise provided in the Global Development Plan and subject to Section 2.8, (i) Servier shall be solely responsible and have the final authority with respect to regulatory activities regarding the Product in the Licensed Territory in the Field and (ii) EOS shall be responsible and have the final authority with respect to all regulatory activities regarding the Product in the Retained Territory in the Field. Except for those clinical studies commenced prior to the Effective Date and unless otherwise provided in Section 3.2 (a) or agreed by the Parties, Servier shall be the sponsor of all clinical studies of the Product performed in the Licensed Territory, and EOS (or its designee) shall be the sponsor of all clinical studies performed in the Retained Territory.

4.2 Ownership of Regulatory Dossier . Servier will own all Regulatory Materials for the Product in the Licensed Territory and EOS will own all Regulatory Materials for the Product in the Retained Territory, for all Indications.

4.3 Regulatory Rights and Responsibilities. Each Party shall use Diligent Efforts to prepare and file all necessary Regulatory Materials for the Product with Regulatory Authorities in accordance with the respective responsibilities of the Parties as set forth in the Global Development Plan. Each Party shall, unless prohibited by law, keep the other Party informed of material regulatory developments relating to the Product in its respective territory through regular reports at the JDC meetings. Each Party shall send Regulatory Materials intended to be submitted to the FDA or the EMA or Japan FDA in draft form to the other Party and give the latter thirty (30) days, or in the event of urgent filings, any shorter reasonable period of time to comment on such drafts of Regulatory Materials, such comments to be considered in good faith and included by the Party receiving these comments in its sole discretion. Each Party

 

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shall notify the other Party of any Regulatory Materials (other than routine correspondence) submitted to or received from the FDA or the EMA and shall provide the other Party with copies thereof. Each Party shall inform the other Party of any Regulatory Materials submitted to or received from any Regulatory Authorities other than the EMA and the FDA that may materially impact the Development or Commercialization of the Product in the other Party’s territory. Each Party shall provide the other Party with reasonable advance notice of all material meetings, conferences, and discussions scheduled with the EMA and the FDA and Japan FDA concerning the Product, and shall consider in good faith any input from the other Party in preparing for such meetings, conferences or discussion.

4.4 Know-How Transfer; Rights of Reference; Use of Data .

(a) Promptly after the Effective Date, EOS shall work with Servier or its designee to facilitate the timely transfer of the EOS Know-How to Servier or its designee (other than the EOS Know-How related to Manufacturing, which is covered by Section 6.5). Such transfer shall occur in a manner and following a reasonable schedule to be established by the JSC. No later than within thirty (30) days following the Effective Date, EOS shall provide access to Servier or its designee copies of relevant material, Information, reports and data, including pre-clinical data, clinical data, and any data that have been provided to Regulatory Authorities for the purpose of obtaining Regulatory Approval for the Product. During the Term, each Party shall promptly make available to the other Party all data and results generated under any Global Development Plan and, with respect to data and results generated under Unsponsored Work and Territory Specific Work, for use in accordance with Section 3.5.

(b) Subject to Sections 3.1 and 3.5, each Party (and its Affiliates and sublicensees) shall have the right to cross reference, file or incorporate by reference any Regulatory Materials filed by the other Party or its Affiliates (or for which EOS has a right of reference) for the Product in order to enable such Party (and its Affiliates and sublicensees) to Develop, obtain Regulatory Approval, Manufacture and Commercialize the Product. Subject to Sections 3.1 and 3.5, each Party shall, on written request by the other Party, provide to the other Party and to any specified Regulatory Authority a letter, in the form reasonably required by the other Party, acknowledging that the other Party (or its Affiliates and sublicensees) has the above right of reference to any such Regulatory Materials.

(c) Any pre-clinical, clinical or other data disclosed to EOS by Servier under this Agreement is provided on an “as is” basis, without any warranty (express or implied) of any kind, and Servier expressly disclaims all such warranties to the maximum extent permitted under applicable law. EOS on behalf of itself and its Affiliates and sublicensees accepts all risk and liability in relation to the use of the data received from Servier under this Agreement and shall indemnify and hold harmless Servier from any Third Party’s claim(s) based upon such data as provided in Article 13.

4.5 Recalls. Any decision to initiate a recall or withdrawal of a Product shall be made by Servier in the Licensed Territory and by EOS in the Retained Territory; provided that Parties shall discuss in good faith and coordinate their efforts with respect to any such recalls. In the event of any recall or withdrawal, such Party shall take any and all necessary action to implement such recall or withdrawal in accordance with applicable Laws, with assistance from

 

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the other Party as reasonably requested by the deciding Party. The costs of any such recall or withdrawal shall be borne solely by the deciding Party in the applicable territory, subject to the provisions of Article 13.

4.6 Safety Data Exchange Agreement. As soon as reasonably practicable after the Effective Date, but in no event later than ninety (90) days thereafter, the pharmacovigilance departments of both Parties shall meet and agree on a safety data exchange agreement (“ Safety Data Exchange Agreement ”) which when executed shall be incorporated herein as Exhibit 4.6 .

 

5. C OMMERCIALIZATION

5.1 Overview . Servier shall have sole control and responsibility for the Commercialization of Products in the Licensed Territory and shall bear all costs and expenses associated with the Commercialization of Products in the Licensed Territory; and EOS shall have sole control and responsibility for the Commercialization of Products in the Retained Territory and shall bear all costs and expenses associated with the Commercialization of Products in the Retained Territory.

5.2 Ex-Territory Sales . Neither Party (and their respective sublicensees or Affiliates) shall engage in any advertising or promotional activities relating to the Product directed primarily to customers or other buyers or users of the Product located outside its territory or accept orders for Products from or sell Products into such other Party’s territory.

5.3 Trademarks. Servier shall have the right to brand the Products in the Licensed Territory using trademarks and trade names it determines appropriate for the Products, which may vary by country or within a country ( “Product Marks” ). Each Party shall not, and shall ensure that its Affiliates and sublicensees will not, make any use of the trademarks or house marks of the other Party or its Affiliates or licensees (including their corporate names) or any trademark confusingly similar thereto. Servier shall own all rights in the Product Marks and shall register and maintain the Product Marks in the Licensed Territory as it determines reasonably necessary at its own cost and expense.

5.4 Commercial Diligence. During the Term, Servier shall use Diligent Efforts to Commercialize the Products in the Licensed Territory. It is anticipated that the application of Diligent Efforts may result, in the case of Servier, in its determination not to seek Regulatory Approval for and/or Commercialize the Product in one or more countries of the Licensed Territory.

5.5 Reporting . Servier shall provide EOS with written reports no less frequently than semiannually following Marketing Authorization summarizing Servier’s (and its Affiliates’ and sublicensees’) efforts to Commercialize Products in the Licensed Territory. All such reports shall be considered Confidential Information of Servier.

 

6. M ANUFACTURING

6.1 Overview . In general and subject to the terms of this Agreement, (a) EOS shall be responsible for Manufacturing Product for clinical use and Development activities (including CMC activities) under the Global Development Plan until Servier takes over such

 

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Manufacturing activities in accordance with the Transition Plan following the transfer of technology contemplated in Section 6.5 (the “ Manufacturing Transfer ”), and (b) each Party shall be responsible for Manufacturing the Product for Commercialization in its respective territory. Servier shall take over Manufacturing for Development activities (including CMC activities) under the Global Development Plan and Transition Plan promptly following the Effective Date, using for an interim period of time the Third Party manufacturers used by EOS in connection with the Product, and then, in Servier’s sole discretion, any other Manufacturing facility(ies) of Servier, its Affiliate or any Third Party.

6.2 Manufacturing Plan. The Parties shall establish a plan for CMC Activities, including process development and scale-up, Manufacture of the Product and any other matters related to the Manufacture of the Product, as well as a budget for such activities, such a plan will be submitted for approval to the JSC (the Manufacturing Plan ). The Manufacturing Plan shall contain all activities necessary or useful to transfer all EOS Know-How and enable Servier, its Affiliates, or such Third Party manufacturer (as appropriate) to Manufacture the Product, at Servier’s request, in accordance with Section 6.5. The Parties, shall make good faith efforts to establish such initial Manufacturing Plan and have it approved by the JSC within ninety (90) days after the Effective Date.

6.3 Supply of Product for Clinical Use; Quality Agreement . Until the Manufacturing Transfer, EOS, and thereafter, Servier shall Manufacture, supply and sell all Products for clinical use and Development activities under the Global Development Plan at a price equal to their respective Manufacturing Costs and pursuant to the terms of the clinical supply agreement to be entered within ninety (90) days of the Effective Date (the “ Clinical Supply Agreement ”). Manufacture and supply of Product for clinical use will be included within CMC Activities under the Manufacturing Plan, and all related costs will be included in CMC Costs under Section 3.2(b). In connection with the Clinical Supply Agreement, the Parties shall enter into a separate quality agreement setting forth the responsibilities of the quality organizations of each Party with respect to the cGMP manufacture of the Product (the “ Quality Agreement ”).

6.4 Manufacturing Costs . For the avoidance of doubt, no cost or expense shall be counted more than once in calculating actual Manufacturing Costs, and if such cost or expense falls into more than one of the cost categories that comprise such cost and/or Development Costs, it shall be allocated only once to the Manufacturing Costs.

6.5 Transfer of EOS Know-How and Manufacturing Technology . Upon Servier’s request, EOS, at Servier’s cost and expense, shall (and make Commercially Reasonable Efforts to cause its Third Party manufacturer to) promptly disclose (and provide copies, as applicable) to either Servier or a Third Party manufacturer selected by Servier, all EOS Know-How necessary or useful to enable Servier or such Third Party manufacturer (as appropriate) to Manufacture the Product. For clarity, nothing in this Section 6.5 with respect to EOS’ obligation to transfer EOS Know-How to Servier shall limit EOS’ right to use any such EOS Know-How to fulfill EOS’ obligations to Manufacture and supply the Product for use in the Retained Territory. In addition, EOS shall (and make Commercially Reasonable Efforts to cause its Third Party manufacturer to) make available to Servier, on a reasonable consultation basis, advice of its technical personnel at Servier’s expense as may reasonably be requested by Servier in

 

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connection with such transfer of EOS Know-How. In accordance with the agreed budget as provided in the Manufacturing Plan, Servier shall reimburse EOS for the FTE Costs when consulting for Servier. Servier shall reimburse EOS for reasonable travel expenses incurred by personnel of EOS at the request of Servier while rendering services under this Section 6.5.

6.6 Retained Territory.

(a) Servier shall have no obligation to supply the Product to EOS for Development in the Retained Territory beyond the Global Development Plan, or for Commercialization in the Retained Territory.

(b) At the reasonable request of EOS and at EOS’ cost and expense, Servier shall (and make Commercially Reasonable Efforts to cause its Third Party manufacturer to) promptly disclose (and provide copies, as applicable) to either EOS or a Third Party manufacturer selected by EOS, all know-how of Servier as necessary to enable EOS or such Third Party manufacturer (as appropriate) to Manufacture the Product for Development and Commercialization in the Retained Territory.

(c) Servier hereby grants to EOS a royalty free, perpetual, fully-paid license, under the Patents and know how of Servier as actually used at the time of the transfer of technology as set forth in Section 6.6 (b) by Servier in Manufacturing the Product pursuant to this Agreement and as necessary to Manufacture the Product for Development and Commercialization in the Retained Territory, provided however that if this Agreement is terminated by Servier for EOS’ breach pursuant to Section 11.4, the license granted to EOS pursuant to this subclause (c) shall immediately terminate. EOS shall have the right to grant a sublicense under the rights set forth in the preceding sentence only to Affiliates or Third Party Partners, provided that, with respect to any Third Party Partner, such Third Party Partner grants to Servier similar rights and licenses corresponding to those granted by Servier (i) under this subclause (c) (royalty free, perpetual, fully-paid license under the Patents and know how of such Third Party Partner as actually used by such Third Party Partner in Manufacturing the Product and necessary to Manufacture the Product for Development and Commercialization in the Licensed Territory), and (ii) under subclause (b) above (transfer of technology at Servier’s cost and expense).

 

7. L ICENSES AND R ELATED R IGHTS

7.1 Licenses to Servier .

(a) License Grant . Subject to the terms and conditions of this Agreement, EOS hereby grants to Servier, and Servier hereby accepts:

(i) an exclusive (even as to EOS) royalty-free license, with the right to sublicense as provided in Section 7.1(c), under the EOS Technology to Develop Products solely in accordance with the Global Development Plan, Unsponsored Work and Territory Specific Work in the Field in and/or for the Licensed Territory during the Term;

(ii) an exclusive (even as to EOS), royalty-bearing license, with the right to sublicense as provided in Section 7.1(c), under the EOS Technology to use, sell, offer for sale, distribute, import, export and otherwise Commercialize Products in the Field in the Licensed Territory during the Term; and

 

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(iii) from the date of the Manufacturing Transfer, an exclusive (even as to EOS subject to Section 7.1 (b)), worldwide, royalty-free license under the EOS Technology, with the right to sublicense as provided in Section 7.1(c), to make and have made the Product for use in the Development or Commercialization of Products in the Field in the Licensed Territory.

(b) EOS Retained Rights . It is understood that at all times EOS and its Affiliates retain (i) the exclusive right to Develop and Commercialize (including manufacturing) the Product in the Retained Territory, (ii) the right to practice the EOS Technology as and to the extent needed in connection with its activities under this Agreement in fulfillment of its obligations hereunder, (iii) the right to Manufacture the Product (including in the Licensed Territory) for use in the Development or Commercialization of Product in the Retained Territory and (iv) subject to Section 7.2, the right to use and practice the EOS Technology outside the scope of the licenses granted to Servier in Section 7.1(a).

(c) Sublicense Rights. Servier shall have the right to grant sublicenses (through one or more tiers) of the licenses granted to it under Section 7.1(a) to any of its Affiliates and Third Parties without EOS’ consent; provided that (a) Servier hereby covenants that it will include in all agreements granting sublicenses to Third Party under the rights granted in this Agreement provisions consistent with the terms of this Agreement as applicable to a sublicensee and (b):

(i) any such sublicense must refer to this Agreement and shall be subordinate to and consistent with the terms and conditions of this Agreement, and shall not limit: (i) the ability of Servier (individually or through the activities of its sublicensees) to fully perform all its obligations under this Agreement or (ii) EOS’ rights under this Agreement;

(ii) any sublicenses granted by Servier to others under this Section to sell Products that are subject to royalty payments under this Agreement must include an obligation for the sublicensee to account for and report its sales of Products to Servier on the same basis as if such sales were Net Sales by Servier. Servier shall remain responsible to EOS for all development and sales milestones for such Products under this Agreement;

(iii) if Servier grants a sublicense to any Third Party, then Servier shall provide EOS with a redacted copy of each such sublicense containing provisions relevant to this Agreement, promptly after execution thereof; and

(iv) upon early termination (except for termination by Servier under Section 11.4 (Termination for Material Breach) of this Agreement with respect to any country of the Licensed Territory, all such sublicenses shall immediately terminate with respect to such country.

7.2 Negative Covenants . EOS agrees that beginning on the Effective Date and ending five (5) years after the First Commercial Sale of the Product in the Licensed Territory, it shall not, itself or through one or more Affiliates or Third Parties (including any Third Party Partner), clinically develop, sell, offer for sale, distribute, promote or market any Competing Product in the Licensed Territory.

 

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7.3 No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party. Neither Party shall engage in any activities that use the other Party’s technology in a manner that is outside the scope of the rights granted under this Agreement.

7.4 Advenchen Agreement .

(a) EOS shall not amend any terms or conditions of the Advenchen Agreement in any manner that could adversely affect the rights granted to Servier under this Agreement in any respect without the prior written consent of Servier. EOS further agrees that it shall not terminate or waive any of its rights under the Advenchen Agreement without the prior written consent of Servier, which will not be unreasonably withheld. EOS shall notify Servier when it has received any notice from Advenchen stating that EOS has breached or may breach the Advenchen Agreement or that Advenchen intends to terminate or is terminating the Advenchen Agreement.

(b) Upon Servier’s request, EOS shall use its commercially reasonable efforts to obtain from Advenchen a letter confirming that in the event of termination of EOS’ rights under the Advenchen Agreement, Servier shall have the possibility to become a direct licensee of Advenchen as set forth in section 14.6 of the Advenchen Agreement. Servier shall be given the opportunity to review and approve the content of the abovementioned letter prior to its submission for signature to Advenchen.

(c) As soon as reasonably practicable after the Effective Date, EOS shall use its commercially reasonable efforts to request that Advenchen take the ADBK Actions. Unless otherwise agreed by the Parties, the milestone payment corresponding to the granting of European Patent 2125777 as provided for in subsection 8.3 below, if otherwise due and payable by Servier, shall not be paid or payable to EOS until the earliest of (i) such ADBK Actions are taken or (ii) such EOS Patents held by Advenchen have expired to the extent that Servier has benefited from the licenses and related rights granted hereunder until such expiry date, or (iii) Section 365(n) of the Bankruptcy Code is amended to include non-US Patents in the definition of “intellectual property rights” contained in such Bankruptcy Code so long as Advenchen is a US company. Subsections (i), (ii) and (iii) above shall apply during the Term, and will not survive the termination or expiration of the Agreement.

(d) Notwithstanding any provision to the contrary in this Agreement and without limiting any other right or remedy of Servier under this Agreement, in the event that the Advenchen Agreement is rejected in a federal bankruptcy proceeding and not assumed by a Third Party in a manner that does not affect any of Servier’s rights hereunder, then Servier may, at its sole discretion, either (i) terminate the Agreement for material breach by EOS pursuant to Section 11.4 or (ii) suspend all or part of its obligations hereunder. In all circumstances, EOS shall take all appropriate actions in relation to the Advenchen Agreement to preserve Servier’s rights under this Agreement (as a sublicensee under the Advenchen Agreement).

 

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7.5 EOS’ Covenants and Lien .

(a) During the Term, EOS shall: (i) not incur any debt (including bank debt, bonds, convertible bonds or other, but excluding any obligations hereunder, any operating liabilities of EOS incurred in the ordinary course of business and any liabilities to shareholders of EOS) in excess of its net worth and (ii) maintain net worth in excess of one (1) Million Euros (excluding any obligations hereunder, any operating liabilities of EOS incurred in the ordinary course of business and any liabilities to shareholders of EOS). EOS shall provide no later than March 31 of each calendar year, and at any time during the Term, upon Servier’s request made no more frequently than quarterly, a balance sheet (audited at least once each calendar year) prepared in accordance with GAAP with regard to its debt and net worth. EOS shall also immediately notify to Servier of any event likely to adversely impact EOS’ financial situation with an assessment of such impact, and provide all information and documents reasonably requested by Servier in this respect. In consideration of the amount received pursuant to Section 8.2 and its other rights pursuant to this Agreement, EOS hereby shall assign to Servier the EOS Patents (excluding any Patent granting rights with respect to the Retained Territory) owned by EOS effective upon EOS’ breach of the covenants set forth in this Section 7.5 (a). Within ninety (90) days following Servier’s request, the Parties shall execute any additional document as may be useful to perfect such conditional assignment. If such assignment becomes effective, (i) Servier shall grant to EOS a royalty free, fully paid up, perpetual, license, with the right to sublicense, under such EOS Patents to exercise the Retained Rights as set forth in Section 7.1 (b) and (ii) in the event of termination of this Agreement by Servier pursuant to Sections 11.2 or 11.3 or by EOS pursuant to Section 11.4, such EOS Patents shall be assigned back to EOS, at no cost to EOS. For the avoidance of doubt, the effectiveness of such assignment to Servier shall have no effect on Servier’s obligations pursuant to this Agreement.

(b) As soon as practicable, and in any event within one hundred and twenty (120) days following the Effective Date, in order to secure EOS’ obligations pursuant to Section 7.5 (a) and Servier’s damages in the event that the licenses granted by EOS to Servier under Section 7.1 are terminated otherwise than as contemplated under Sections 11.2 to 11.5, EOS shall grant to Servier a first priority lien on the EOS Patents (excluding any Patent granting rights with respect to the Retained Territory) owned by EOS, or such other form of charge, pledge or security interest as may be appropriate under the Laws governing such intellectual property, and EOS shall execute, deliver, and file in the appropriate registers all such documents and instruments as may be required to grant and perfect such lien.

 

8. PAYMENTS

8.1 Notification, Payment and Invoicing . Any and all amounts payable by a Party to the other Party under this Agreement shall be invoiced as follows:

(a) by EOS to Servier: 50 rue Carnot, 92284 Suresnes Cedex, France to the attention of Direction de la Coopération Scientifique. Servier shall notify in due time to EOS which legal entity between Les Laboratoires Servier and Institut de Recherches Internationales Servier has to be invoiced.

 

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(b) by Servier to EOS: Via Monte di Pietá, 1/A, 20121 Milan, Italy, to the attention of the Chief Executive Officer. For all payments due pursuant to Sections 8.3 and 8.4 below, payment shall be made within forty five (45) days of the date of the corresponding invoice. Each Party shall inform the other Party promptly and no later than within thirty (30) days of the occurrence of an event triggering a payment obligation on the informing Party.

8.2 Upfront Payment. Within thirty (30) days after the Effective Date (and subject to the submission of an invoice within three (3) days of the Effective Date), Servier shall pay to EOS a one-time, non-refundable and non-creditable upfront cash payment of Forty-Five Million Euros (€45,000,000).

8.3 European Patent 2125777. Subject to section 7.4(c), after (i) the granting by the European Patent Office (EPO) of patent EP 2125777, or (ii) the end of opposition and/or appeal, if any, of patent EP 2125777, whichever is later, Servier shall pay to EOS a one-time, non-refundable and non-creditable milestone payment of *** Euros (€***).

8.4 Milestone Payments.

(a) General. Servier shall make one-time, non-refundable and non-creditable milestone payments to EOS as provided below after the achievement of each applicable milestone event by Servier or its Affiliates or sublicensees.

(b) Development and Regulatory Milestones for Indications. The following milestone payments shall be payable to EOS for the Product to achieve the following milestone events:

 

Milestone Event

   Milestone Payment

Upon obtaining Clinical Trial Approval for the first Phase 3 Clinical Trial or Pivotal Clinical Trial for a first Indication for the Product in the Licensed Territory

   €***

Upon obtaining Clinical Trial Approval for the first Phase 3 Clinical Trial or Pivotal Clinical Trial for a second Indication for the Product in the Licensed Territory

   €***

Upon obtaining Clinical Trial Approval for the first Phase 3 Clinical Trial or Pivotal Clinical Trial for a third Indication for the Product in the Licensed Territory

   €***

MAA Filing for the first Indication of the Product

   €***

Approval by European Commission of the first Marketing Authorization Application for the first Indication of the Product

   €***

 

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For clarity, the maximum total amount payable under this Section 8.4(b) if all milestones are achieved would be €***. For further clarity, the maximum number of Indications for which Servier would owe milestones under this Section 8.4(b), in the aggregate, is three (3).

(c) Sales Milestones. Servier shall make the following one-time, non-refundable and non-creditable sales milestone payments to EOS when the aggregate Net Sales of all Products in the Licensed Territory (not any particular country or region) first reach the thresholds specified below in any four (4) consecutive calendar quarters.

 

Threshold for Aggregate

Net Sales in the Licensed Territory

   Milestone Payment

€***

   €***

€***

   €***

€***

   €***

€***

   €***

To the extent more than one sales threshold is reached in any given four (4) consecutive calendar quarters, then the applicable milestone payment for each such achievement shall be due and owing with respect to such period.

8.5 Royalty Payments.

(a) Royalties in Licensed Territory. Servier shall pay to EOS quarterly royalties on Net Sales of Products in the Licensed Territory (not any particular country or region) during such calendar quarter, on a Product-by-Product basis, as calculated by multiplying the total Net Sales of such Product during such calendar quarter by the applicable royalty rate as determined in the following royalty rate table. For purposes of determining the applicable royalty rate, all Net Sales of the Product in the Licensed Territory shall be aggregated.

 

Net Sales of Product

   Royalty Rate  

For that portion of calendar year Net Sales less than or equal to *** Euros (€***)

     ***

For that portion of calendar year Net Sales greater than *** Euros (€***) but less than or equal to *** Euros (€***)

     ***

For that portion of calendar year Net Sales greater than *** Euros (€***)

     ***

 

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(b) Royalty Term. Royalties under this Section 8.5 in each country will be payable starting as of the First Commercial Sale and only to the extent there is in such country a *** under this Agreement and Covering the sale or use of the Product or Data Exclusivity relating to the Product (such term being defined, on a country by country basis as the “ Royalty Term ”).

(c) Royalty Adjustments.

(i) Third Party License. If, after the Effective Date, Servier or its sublicensee or designee: (A) reasonably determines that it is necessary or useful to obtain a license from any Third Party under patent rights controlled by such Third Party in order to make, have made, use, sell, offer for sale or import a Product in any country, and pursuant to such license is required to pay a royalty or other payments to the Third Party, or (B) is required by any court of competent jurisdiction, due to infringement of patent rights controlled by such Third Party in any country(ies), to pay a royalty or other payments (including damages) to such Third Party, then Servier may deduct from the royalties that would otherwise be due to EOS fifty percent (50%) of any such amount paid by Servier to such Third Party; provided that the deduction pursuant to this Section 8.5(c)(i) shall not reduce the royalties due to EOS for any Product below fifty percent (50%) of the amount that otherwise would have become due for such country in any calendar quarter; provided further that any such amount of reduction not utilized in a calendar quarter may be carried over to following calendar quarters for reduction by Servier.

(ii) Patent Expiry. On a country-by-country basis, if there is no Valid Claim of any EOS Patent licensed to Servier under this Agreement and Covering the composition of matter of the Product or Data Exclusivity relating to the Product, then the royalty rates under Section 8.5(a) shall be reduced by fifty percent (50%).

(iii) Generic Product. On a country-by-country basis, if, during any calendar quarter, the unit volume of sales of all such Generic Product(s) in such country during such quarter are more than *** percent (***%) of the total unit volume of sales of (i) all such Generic Product(s) plus (ii) such Product’s unit volume of sales in such country, then the royalty rates under Section 8.5(a) as adjusted pursuant to Section 8.5(c) (ii) if applicable, shall be reduced by fifty percent (50%). The percentage of sales of the Generic Product relative to all sales of unlicensed products and Products shall be based on unit-equivalent data, calculated using data provided by IMS or, in the absence of such publication by IMS, any similar market data source, or if such data is not available, another reliable data source that is mutually acceptable to EOS and Servier.

(d) Royalty Reports and Payments . During the Royalty Term and within forty five(45) days following the end of each calendar quarter following the First Commercial Sale of a Product by Servier or its Affiliate or sublicensee anywhere in the Licensed Territory, Servier shall provide EOS with a report containing the following information for the applicable calendar

 

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quarter, on a Product-by-Product basis: (i) gross sales and Net Sales of Product consolidated in Euros, (ii) a calculation (including the basis of such calculations) of the royalty payment due on such sales, (iii) the adjustment, if any, made in accordance with the terms of Section 8.5(c), as well as any other details reasonably requested by EOS. Within fifteen (15) days of providing the report to EOS, Servier shall proceed to the payment of the royalties due by wire transfer of immediately available funds.

8.6 Payment Method. All payments due under this Agreement to EOS shall be made in Euros by bank wire transfer in immediately available funds to an account designated by EOS.

8.7 Late Payment. If either Party fails to make any payment due to the other Party under this Agreement, then interest shall accrue on a daily basis at the rate equal to one month EURIBOR plus ten (10) basis points per annum, or at the maximum rate permitted by applicable Law, whichever is the lower.

8.8 Foreign Exchange. Conversion of sales recorded in local currencies to Euros shall be performed in a manner consistent with Servier’s normal practices used to prepare its audited financial statements for internal and external reporting purposes, which uses a widely accepted source of published exchange rates.

8.9 Records; Inspection. During the Royalty Term, Servier shall, and shall ensure that its Affiliates and sublicensee(s) will, keep complete, true and accurate books of account and records for the purpose of determining the payments to be made under this Agreement. Such books and records shall be kept for at least three (3) years following the end of the calendar year to which they pertain. Such records shall be open for inspection during such period by independent accountants reasonably acceptable to Servier (who shall agree with Servier to keep such records confidential), solely for the purpose of verifying payment statements hereunder. Such inspections shall be made no more than once each calendar year, on reasonable notice during normal business hours, and shall solely relate to the three (3) preceding calendar years. Any underpayment or overpayment (plus interest as set forth in Section 8.7) that are discovered shall be paid by the owing Party within thirty (30) days. Inspections conducted under this Section 8.9 shall be at the expense of EOS, unless the inspection discloses an underpayment by Servier of *** percent (***%) or more of the amount due for any period covered by the inspection, whereupon the reasonable fees of the independent accountant relating to the inspection for such period shall be paid promptly by Servier.

8.10 Taxes .

(a) Taxes on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the efforts of the Parties under this Agreement.

(b) Taxes and withholding. All payments due and payable under this Agreement will be made without any deduction or withholding for or on account of any tax unless such deduction or withholding is required by applicable laws. If the paying Party is so required to deduct or withhold, such Party will (a) promptly notify the other Party of such requirement, (b)

 

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pay to the relevant authorities the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against the other Party, and (c) promptly forward to the other Party an official receipt (or certified copy) or other documentation reasonably acceptable to the other Party evidencing such payment to such authorities.

(c) Other Taxes. Each Party shall be solely responsible for the payment of Value Added Tax, custom duties, registration duties, transfer taxes, stamp duties and any other taxes or duties imposed to it in relation with the payments made under this Agreement.

(d) EOS Obligations. The provisions of subsections (b) and (c) above shall apply mutatis mutandis to EOS where EOS is the paying Party.

(e) Set Off. Notwithstanding any other provisions herein, Servier shall be entitled to offset any payment due by Servier to EOS pursuant to this Article 8 against any amounts owed by EOS to Servier pursuant to Section 3.2(b).

 

9. INTELLECTUAL PROPERTY

9.1 Ownership . Each Party shall own all inventions, Information and other intellectual property, whether or not patentable, made solely by its or its Affiliates’ own employees, agents, or independent contractors in the course of conducting its or its Affiliates’ activities under this Agreement, together with all intellectual property rights therein (“ Sole Inventions ”). The Parties shall jointly and equally own any inventions, Information and other intellectual property, whether or not patentable, that are made jointly by employees, agents, or independent contractors of each Party or its Affiliates in the course of conducting its or its Affiliates’ activities under this Agreement (including pursuant to the Global Development Plan), together with all intellectual property rights therein (“ Joint Inventions ”). Inventorship shall be determined in accordance with Swiss law. All Patents claiming patentable Sole Inventions (but not Joint Inventions) shall be referred to herein as “ Sole Invention Patents ”. All Patents claiming patentable, jointly owned Joint Inventions shall be referred to herein as “ Joint Invention Patents ”. Servier hereby grants to EOS an exclusive license, with the right to sublicense, under its interest in the Joint Invention Patents for use in the Development, Manufacture and Commercialization of the Product in and for the Retained Territory in the Field. Except to the extent either Party is restricted by the licenses and rights granted to the other Party or its Affiliates under this Agreement, including the exclusive license from EOS to Servier with respect to the Product in the Licensed Territory and the Field and the exclusive license from Servier to EOS with respect to the Product in and for the Retained Territory and the Field, each Party and its Affiliates shall be entitled to practice and exploit (including through the grant of licenses in its territory) the Joint Inventions and the Joint Invention Patents without the duty of accounting or seeking consent from the other Party.

9.2 Disclosure. Each Party shall promptly disclose to the other Party all Sole Inventions and Joint Inventions, including any invention disclosures or other similar documents, submitted to it by its or its Affiliates’ employees, agents or independent contractors describing inventions that are either Sole Inventions or Joint Inventions, and all Information relating to such inventions to the extent necessary for the preparation, filing and prosecution of any Patent with

 

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respect to such invention. Upon the disclosure of a Joint Invention or Sole Invention pursuant to this Section 9.2, the Parties shall promptly discuss such Joint Invention or Sole Invention and (a) confirm its status as either a Joint Invention or a Sole Invention in light of the ownership principles set forth in Section 9.1 and (b) determine whether to file a patent application claiming such Joint Invention or Sole Invention; provided that the Party owning such Sole Invention shall nonetheless have the right to file for such patent application.

9.3 Patent Prosecution.

(a) EOS Patents and Joint Invention Patents.

(i) Licensed Territory . Except as otherwise provided in this Section 9.3(a)(i), Servier shall have the first right, but not the obligation, to prepare, file, prosecute and maintain, at Servier’s sole cost and expenses, the EOS Patents and Joint Invention Patents in the Licensed Territory, using patent counsel reasonably acceptable to EOS. To that effect, EOS shall (i) obtain and provide to Servier all necessary powers of attorney to file, prosecute and maintain the EOS Patents (including the Patents owned by Advenchen listed in Exhibit 1.33 ) and Joint Invention Patents in the Licensed Territory and (ii) provide to Servier promptly following their receipt, all material communications regarding such EOS Patents (including the Patents owned by Advenchen listed in Exhibit 1.33 ) and Joint Invention Patents in the Licensed Territory. The Parties shall discuss and confer with respect to the overall patent strategy with respect to the EOS Patents and any Joint Invention Patents in the Licensed Territory and Retained Territory. Servier shall provide EOS reasonable opportunity to review and comment on all material communications and actual and prospective filings and submissions regarding such EOS Patents and Joint Invention Patents in the Licensed Territory, including by providing EOS with a copy of material communications from any patent authority in the Licensed Territory regarding such EOS Patents and Joint Invention Patents, and by providing drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses, provided that Servier shall have final decision making authority with respect to the preparation, filing, prosecution and maintenance of the EOS Patents and Joint Invention Patents in the Licensed Territory. Notwithstanding the foregoing, if Servier determines in its sole discretion to abandon or not maintain any EOS Patent or any Joint Invention Patent in the Licensed Territory or in any particular country, or to not file for rights in any particular country with respect to any EOS Patent or Joint Invention Patent, then Servier shall notify EOS not less than two (2) months before any relevant deadline , and thereafter EOS shall have the right, but not the obligation, to pursue, at EOS’s expense and in EOS’s sole discretion, prosecution of such EOS Patent. If Servier no longer wishes to maintain or prosecute any Joint Invention Patents in the Licensed Territory, then Servier shall give reasonable notice to EOS, and thereafter, EOS may, upon written notice to Servier, prosecute and maintain such Joint Invention Patent, in which case, Servier shall assign at no cost to EOS its interest in such Joint Invention Patent so that it shall become solely owned by EOS and no longer be considered as a Joint Invention Patent but as an EOS Patent for purposes of this Agreement.

(ii) Retained Territory. In the Retained Territory, EOS shall have the sole authority and control over the preparation, filing, prosecution and maintenance of the EOS Patents and Joint Invention Patents in the Field, at EOS’ sole cost and expense, provided that EOS shall update Servier from time to time on the status of such Patent prosecution and

 

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maintenance efforts. With respect to the Joint Invention Patents, EOS shall keep Servier advised of the status of all communications and actual and prospective filings and submissions regarding the Joint Invention Patents in the Retained Territory, and shall give Servier a reasonable opportunity to review and comment on any such communications, filings, filing date and submissions proposed to be sent to any patent office, including by providing Servier with a copy of material communications from any patent authority in the Retained Territory regarding such EOS Patents and Joint Invention Patents, and by providing drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. If EOS no longer wishes to maintain or prosecute any Joint Invention Patents in the Retained Territory, then EOS shall give reasonable notice to Servier, and thereafter, Servier may, upon written notice to EOS, prosecute and maintain such Joint Invention Patent, in which case, EOS shall assign at no cost to Servier its interest in such Joint Invention Patent so that it shall become solely owned by Servier and no longer be considered as a Joint Invention Patent for purposes of this Agreement.

(b) Patent Term Extension. EOS and Servier shall cooperate with each other and shall use Diligent Efforts in obtaining patent term extensions or supplemental protection certificates or their equivalents in any country to the EOS Patents and Joint Invention Patents.

(c) Cooperation. Each Party shall provide the other Party all reasonable assistance and cooperation in the patent prosecution efforts provided above in this Section 9.2, including providing any necessary information, documents, and powers of attorney, and executing any other required documents or instruments for such prosecution.

9.4 Enforcement of Patents.

(a) Notification and Dispute Resolution . If either Party becomes aware of any existing or threatened infringement of any EOS Patents or Joint Invention Patents, which infringing activity involves the manufacture, use, import, offer for sale or sale of any Product in the Licensed Territory (a “ Product Infringement ”) or Retained Territory, it shall promptly notify the other Party in writing to that effect, and the Parties will consult with each other regarding any actions to be taken with respect to such Product Infringement. The Party bringing an infringement action pursuant to this Section 9.4 shall have sole and final decision making authority with respect to any strategy or litigation tactics related to such Product Infringement.

(b) EOS Patents and Joint Invention Patents. In the Licensed Territory, Servier shall have the first right, but shall not be obligated, to bring an infringement action against any person or entity engaged in a Product Infringement of the EOS Patents and Joint Invention Patents, at Servier’s cost and expense provided , however , that (i) to the extent reasonably practicable, prior to initiating any such suit or proceeding, the Parties shall discuss the extent and impact of the Product Infringement; and (ii) Servier shall promptly disclose to EOS all material information related to such action. If Servier or any of its sublicensees does not desire to bring such an action or to continue to pursue such action with respect to any such Patent (or to settle or otherwise secure the abatement of such Product Infringement), it shall so notify EOS within ninety (90) days following Servier’s receipt or delivery of the notice under Section 9.4(a), in which event EOS shall have the right to bring and control any such action, at its own expense and by counsel of its own choice, unless Servier reasonably objects to such

 

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action for likely having a material adverse effect upon the Commercialization (including profitability) of the Licensed Product in the Licensed Territory. In the Retained Territory, EOS shall have the first right, but shall not be obligated, to bring an infringement action against any person or entity engaged in a Product Infringement of the EOS Patent and Joint Invention Patents, at EOS’s cost and expense

(c) Cooperation. Each Party shall provide to the enforcing Party under this Section 9.4 reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Laws to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts and shall reasonably consider the other Party’s comments on any such efforts, subject to Section 9.4(a). To the extent that the non-enforcing Party owns or controls the Patent being enforced, it shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the enforcing Party. Neither Party shall have the right to settle any patent infringement litigation in the Licensed Territory under this Section 9.4 without the prior written consent of such other Party, such consent not to be unreasonably withheld or delayed.

(d) Expenses and Recoveries. The enforcing Party bringing a claim, suit or action under Section 9.4(b) shall be solely responsible for any expenses incurred by such Party as a result of such claim, suit or action. If such Party recovers monetary damages in such claim, suit or action, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amounts shall be allocated as follows: (i) in the case of any recovery for a Product Infringement pursuant to an infringement action brought by Servier under Section 9.4(b), such recoveries shall be deemed Net Sales of Servier, and (ii) in the case of any recovery for a Product Infringement of a EOS Patent or Joint Invention Patent brought by EOS under Section 9.4(b), such recoveries shall be allocated ***percent (***%) to EOS and *** percent (***%) to Servier.

9.5 Patent Oppositions and Other Proceedings.

(a) If an EOS Patent or Joint Invention Patent in the Licensed Territory or Retained Territory becomes the subject of any proceeding commenced by a Third Party in connection with an opposition, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or enforceability thereof, then Servier (if in the Licensed Territory) or EOS (if in the Retained Territory) shall have the first right, but not the obligation, to control such defense at its own expense using counsel of its own choice. If Servier decides that it does not wish to defend against such action, it shall notify EOS reasonably in advance of all applicable deadlines, and EOS shall thereafter have the right, but not the obligation, to assume defense of such action at its own expense.

(b) The Party controlling any defense under Section 9.5(a) shall permit the non-controlling Party to participate in the proceedings to the extent permissible under applicable Laws and to be represented by its own counsel at the non-controlling Party’s expense. Notwithstanding any of the foregoing, the Party controlling any infringement action pursuant to Section 9.4(b) shall also have the sole right to control the response to any attack on the validity,

 

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title, or enforceability of a Patent that is asserted by the alleged infringer(s) as a counterclaim or affirmative defense in such action. Neither Party shall have the right to settle any proceeding under this Section 9.5 with respect to any EOS Patent or Joint Invention Patent without the prior written consent of such other Party, such consent not to be unreasonably withheld or delayed.

(c) The Party controlling any defense under Section 9.5(a) will reasonably consider comments of the other Party with respect to any Patent litigation strategy under this Section 9.5, but shall have sole and final decision making authority with respect to such Patent litigation strategy.

9.6 Infringement of Third Party Rights . Without prejudice to the representations and warranties and covenants, if any Product used or sold by Servier or its Affiliates or sublicensees becomes the subject of a Third Party’s claim or assertion of infringement of such Third Party’s intellectual property rights in any jurisdiction in connection with the Development, Manufacture or Commercialization of the Product, then without prejudice to any indemnification obligations, Servier shall promptly notify EOS, and the Parties shall agree on and enter into a “common interest agreement” wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action. Unless agreed otherwise by the Parties and without prejudice to any indemnification obligations, Servier shall be solely responsible for defending itself against any such claim or assertion in the Licensed Territory, at its sole expense. To the extent EOS engages separate counsel in such defense, it would be at its own cost and expense. Servier shall keep EOS fully informed of such claim and its defense, and shall reasonably consider and seek to accommodate any timely comments of EOS with respect thereto.

9.7 No Other Lien . Except as set forth in Section 7.5 (b) and unless otherwise previously agreed in writing by Servier, EOS shall not during the Term (a) grant any lien, pledge, encumbrance, mortgage, security interest, purchase option, call or similar right, conditional and installment sale agreements, charges or claims of any kind (other than licenses in the Retained Territory) (collectively “ Liens ”) with respect to EOS Patents and Joint Invention Patents or (b) permit such a Lien, to attach to any of such rights.

9.8 Patent Marking . Servier shall, and shall require its Affiliates and sublicensees to, mark Products sold by or on behalf of it hereunder with appropriate patent numbers or indicia to the extent permitted by applicable Laws, and only in those countries in which such markings or such notices impact recoveries of damages or equitable remedies available with respect to infringement of EOS Patents or Joint Invention Patents.

 

10. CONFIDENTIALITY

10.1 Confidentiality Obligations. The Parties agree that during the Term and for a period of five (5) years thereafter, a Party receiving Confidential Information of the other Party shall: (a) use Diligent Efforts to maintain in confidence such Confidential Information (but not less than those efforts as such Party uses to maintain in confidence its own proprietary industrial

 

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information of similar kind and value); (b) not disclose such Confidential Information to any Third Party without prior written consent of the other Party, except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties; and (c) not use such other Party’s Confidential Information for any purpose except those permitted by this Agreement or in connection with exercising such Party’s or its Affiliates’ rights and/or fulfilling their obligations under this Agreement or any other agreement between the Parties or their Affiliates.

10.2 Exceptions. The obligations in Section 10.1 shall not apply with respect to any portion of the other Party’s Confidential Information that the receiving Party can show by competent written proof:

(a) was known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the disclosing Party;

(b) was generally available to the public or otherwise part of the public domain, at the time of disclosure by the other Party;

(c) becomes generally available to the public or otherwise part of the public domain after the disclosure by the other Party, other than through any act or omission of the receiving Party in breach of this Agreement;

(d) is subsequently disclosed to the receiving Party by a Third Party who has a legal right to make such disclosure and who did not obtain such information directly or indirectly from the other Party; or

(e) is subsequently independently developed by employees or contractors of the receiving Party who had no access to or knowledge of the other Party’s Confidential Information.

10.3 Authorized Disclosure. A Party may disclose to a Third Party the Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following instances; provided that unless otherwise provided below, notice of any such disclosure shall be provided as soon as practicable to the other Party:

(a) filing or prosecuting Patents in accordance with Section 9.2;

(b) complying with the requirement of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of Products;

(c) prosecuting or defending litigation as contemplated by this Agreement;

(d) disclosure to its or its Affiliates’ employees, agents, consultants, contractors, licensees or sublicensees on a need-to-know basis for the sole purpose of performing its or its Affiliates’ obligations or exercising its or its Affiliates’ rights under this Agreement or any other agreement between the Parties or their Affiliates consistent with the terms of this Agreement; provided that in each case, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement;

 

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(e) disclosure to each Party’s board of directors (or similar governing body) on a confidential basis any bona fide potential or actual investor, sublicensee, acquiror or merger partner or other potential or actual financial partner for the sole purpose of evaluating an actual or potential investment, sublicense, acquisition or other business relationship; provided that in connection with such disclosure, the disclosing Party shall inform each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential Information as confidential; provided, however, that where such potential recipient is a pharmaceutical company, EOS shall not disclose Confidential Information of Servier related to the Global Development Plan or the Product in the Licensed Territory without Servier’s prior written approval which shall not be unreasonably withheld or delayed; or

(f) complying with applicable Laws, including regulations promulgated by applicable security exchanges, court orders or administrative subpoenas or orders

(g) in the case of EOS, disclosure to Advenchen as required pursuant to the Advenchen Agreement.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 10.3(c) or Section 10.3(f), such Party shall promptly notify the other Party of such required disclosure and shall use reasonable efforts to assist the other Party, at such other Party’s expense, in obtaining a protective order preventing or limiting the required disclosure.

10.4 Publicity; Terms of Agreement .

(a) On or promptly after the Effective Date, the Parties shall jointly issue a public announcement of the execution of this Agreement in a form mutually agreed upon. Neither Party shall issue any subsequent press release or make other disclosures regarding this Agreement or the Parties’ activities hereunder, or any results or data arising hereunder, except (a) with the other Party’s prior written consent, such consent not to be unreasonably withheld; or (b) in accordance with Article 10. Notwithstanding the foregoing, to the extent information regarding this Agreement has already been publicly disclosed, either Party may subsequently disclose the same information to the public without the consent of the other Party and provided such information remains accurate as of such time.

(b) If either Party desires to make a public announcement in connection with this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld, except that in the case of a press release or governmental filing required by law, regulation or stock exchange rules, the disclosing Party shall provide the other Party with such advance notice as it reasonably can and shall not be required to obtain approval therefor. A Party commenting on such a proposed press release or governmental filing shall provide its comments, if any, within five (5) business days after receiving the press release for review.

 

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10.5 Technical Publications. Neither Party may publish peer reviewed manuscripts, or give other forms of public disclosure such as abstracts and presentations, of results of studies carried out under this Agreement, without the opportunity for prior review and coordination by the other Party, except to the extent required by applicable Laws. A Party seeking publication shall provide the other Party the opportunity to review and comment on any proposed publication which relates to the Product at least forty-five (45) days (but only five (5) business days for abstracts) prior to its intended submission for publication. The other Party shall provide the Party seeking publication with its comments in writing, if any, within twenty (20) days (but only three (3) business days for abstracts) after receipt of such proposed publication. The Party seeking publication shall consider in good faith any comments thereto provided by the other Party and shall comply with the other Party’s request to remove any and all of such other Party’s Confidential Information from the proposed publication. In addition, the Party seeking publication shall delay the submission for a period up to one hundred and eighty (180) days in the event that the other Party can demonstrate reasonable need for such delay, including the preparation and filing of a patent application. If the other Party fails to provide its comments to the Party seeking publication within such twenty (20)-day period (or three (3) business day period for abstracts), such other Party shall be deemed not to have any comments, and the Party seeking publication shall be free to publish in accordance with this Section 10.5 after the forty-five (45)-day period (or five (5) business day period for abstracts) has elapsed. The Party seeking publication shall provide the other Party with a copy of the manuscript at the time of the submission. Each Party agrees to acknowledge the contributions of the other Party and its employees in all publications as scientifically appropriate, unless such other Party objects.

10.6 Equitable Relief. Each Party acknowledges that its breach of this Article 10 may cause irreparable harm to the other Party, which might not be reasonably or adequately compensated in damages in an action at law. By reasons thereof, each Party agrees that the other Party may be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to seek preliminary and permanent injunctive and other equitable relief to prevent or curtail any actual or threatened breach of the obligations relating to Confidential Information set forth in this Article 10 by the other Party.

 

11. TERM AND TERMINATION

11.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 11, shall remain in effect on a Product-by-Product basis until the expiration of the Royalty Term in the last country of the Licensed Territory and shall continue thereafter for so long as Servier is developing or selling such Product in any country in the Licensed Territory (the “ Term ”). Upon expiration of the Royalty Term for a particular Product in a country, the licenses and rights granted to Servier under this Agreement shall, with respect to such country, become royalty-free, fully paid-up, perpetual (i.e., as long as EOS Know How or other Information licensed hereunder is not publically available), irrevocable and non-terminable.

11.2 Unilateral Termination by Servier . Notwithstanding the above, Servier shall be permitted to terminate the Agreement on a country-by-country basis, without cause and without damages due by Servier to EOS, its Affiliates, licensees or sub-licensees on account of such termination, upon one hundred eighty (180) days prior written notice to EOS (it being understood that Servier shall at all times remain liable for all costs incurred by it under this Agreement during such notice period), but in no event prior to December 31, 2012.

 

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11.3 Termination for Safety Reasons. Notwithstanding Section 11.2, if Servier reasonably determines that the Compound or the Product shows significant safety issue in humans, Servier shall immediately notify EOS, and shall be permitted to terminate the Agreement on a country-by-country basis, promptly, but in any event within thirty (30) days of Servier’s determination of such issue.

11.4 Termination for Material Breach. If either Party believes that the other is in breach of its material obligations hereunder, then the non-breaching Party may deliver notice of such breach to the other Party which notice shall clearly mention the remedies that the non-breaching Party intends to apply should the breach remain uncured. The allegedly breaching Party shall have ninety (90) days from such notice to dispute or cure such breach. If (A) the Party receiving notice of breach fails to cure such breach, or fails to dispute any of the matters described in the next sentence, within such ninety (90)-day period and (B) (i) the uncured material breach is a breach of one or more payment obligations totaling *** (***) *** Euros (€***) or more, or (ii) the uncured material breach cannot be adequately remedied through a combination of specific performance and payment of money damages, then the non breaching Party may terminate this Agreement in its entirety. If the allegedly breaching Party in good faith disputes such material breach or disputes the failure to cure or remedy such material breach or the satisfaction of the conditions set forth in subclause (B) and provides written notice of that dispute to the other Party, the matter shall be addressed under the dispute resolution provisions in Article 14, and the notifying Party may not terminate this Agreement until it has been determined under Article 14 that the conditions for termination of this Section 11.4 are met, in which case, such termination shall then be effective upon written notification from the notifying Party to the breaching Party. For clarification purpose, for Servier’s material breach of its obligations set forth in Sections 3.6 and 5.4, EOS shall only be permitted to terminate the Agreement with respect to those countries to which such breach relates; provided, that with respect to the European Union, Without prejudice to EOS’right of indemnification to seek damages and other remedies hereunder, EOS shall not be permitted to terminate the Agreement pursuant to this Section 11.4 if Servier performs its obligations set forth in Sections 3.6 or 5.4 in at least one country of the European Union.

11.5 Termination for Patent Challenge . If Servier challenges the validity, scope, or enforceability of or otherwise opposes any EOS Patents, then EOS may terminate this Agreement upon thirty (30) days prior written notice, unless Servier withdraws such challenge or opposition within the thirty (30) day notice period. If a sublicensee of Servier challenges or opposes the validity, scope, or enforceability of or otherwise opposes any EOS Patent , then Servier shall, upon thirty (30) days prior written notice from EOS, either (i) terminate such sublicense (ii) cause such sublicensee to withdraw such challenge or opposition, or (iii) cause such sublicensee to terminate such further sublicense or cause such further sublicense to withdraw such challenge or opposition. In the event that all or any portion of this Section is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable, then the Parties will use commercially reasonable efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s).

 

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11.6 Effects of Termination of the Agreement . Upon any early termination of this Agreement (other than, for avoidance of doubt, by operation of Section 11.1), in its entirety or on a country-by-country basis:

(a) Termination of License. Other than termination by Servier on the basis of a material breach of the Agreement by EOS under 11.4, all licenses granted to Servier under Section 7.1 shall terminate, but in the case of termination on a country-by-country basis, solely to the extent such licenses relate to those countries so terminated, provided that Servier shall retain a non-exclusive license under Section 7.1 to sell, offer for sale and import remaining inventories of the Products in terminated countries for a period not exceeding six (6) months.

(b) Termination for Material Breach by EOS . In the case of termination of this Agreement by Servier pursuant to Section 11.4 due to a material breach by EOS, without prejudice to any other remedies of Servier, including the right to claim damages, (i) all licenses granted to Servier under Section 7.1 shall become perpetual, fully paid up and Servier shall no longer have any obligations pursuant to this Agreement, provided however that Servier shall pay to EOS fifty percent (50%) of the royalty payments set forth in Section 8.5 when they would have become due if the Agreement had not been terminated, (ii) all licenses granted by Servier to EOS hereunder shall terminate, and (iii) the Reimbursable Amount (if any) shall become immediately payable by EOS to Servier.

(c) Regulatory Materials; Data. Other than termination on the basis of a public health and safety reason under Section 11.3, or termination by Servier on the basis of a material breach of the Agreement by EOS under Section 11.4, or except where Servier can reasonably demonstrate that Commercializing the Product in the terminated country(ies) is detrimental to Servier’s sales in the non-terminated countries, at EOS’ request which shall be notified to Servier within fifteen (15) days of the termination notice, Servier agrees to transfer to EOS the Regulatory Materials, and Regulatory Approvals, and the related data relating to the Product in such terminated country, subject to Section 11.6 (g) and appropriate indemnification of Servier by a financially capable entity and provided that EOS shall compensate Servier for the costs reasonably incurred by Servier for such transfer.

(d) Termination of Rights and Return of Confidential Information. Upon termination of this Agreement other than a termination by Servier pursuant to Section 11.4 due to a material breach by EOS, or as otherwise expressly provided in this Agreement, Servier shall surrender to EOS, or destroy and provide EOS with a certificate signed by an Executive Officer of Servier attesting to the destruction of, all copies of any Confidential Information provided by EOS hereunder. Upon termination of this Agreement other than a termination by EOS pursuant to Section 11.4 due to a material breach by Servier, EOS shall surrender to Servier, or destroy and provide Servier with a certificate signed by an Executive Officer of EOS attesting to the destruction of, all copies of any Confidential Information provided by Servier hereunder. Notwithstanding the foregoing, a Party may retain one (1) copy of any Confidential Information in an appropriately secure location.

(e) Product Mark. Other than termination on the basis of a public health and safety reason under Section 11.3, or termination by Servier on the basis of a material breach of the Agreement by EOS under Section 11.4, and except where Servier can reasonably demonstrate that Commercializing the Product under the Product Mark in the terminated country(ies) is detrimental to Servier’s sales in the non-terminated countries, at EOS’ request which shall be notified to Servier within fifteen (15) days of the termination notice Servier shall consider in good faith licensing to EOS, for a period of time allowing EOS to switch Product

 

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Mark, any and all Product Marks then being used by Servier solely and exclusively for any such Product and transfer to EOS in the right to use during the transition period any domain names containing solely such Product Marks, in each case only to the extent that such Product Mark has actually been utilized previously by Servier in connection with the Commercialization of the Product in the Licensed Territory and is not used for any other product Controlled by Servier and do not make reference to any other trade name or trademark of Servier. Notwithstanding the foregoing, in connection with any such termination, EOS shall be permitted to utilize such Product Mark to sell existing Products during the 6 month period following any such termination.

(f) Post Termination Technology Transfer . Other than termination on the basis of a public health and safety reason under Section 11.3, or termination by Servier on the basis of a material breach of the Agreement by EOS under Section 11.4 and subject to Section 11.6 (g), at EOS’ request which shall be notified to Servier within fifteen (15) days of the termination notice, Servier shall reasonably cooperate with EOS in order to enable EOS to promptly assume the Development and/or Commercialization of all Compounds and Products (or the particular Compound and/or Product if such termination is only as to one Compound and/or Product) then being Commercialized or in Development by Servier in the Licensed Territory (or in a particular country if such termination is only as to such country). Such cooperation and assistance shall be provided in a timely manner (having regard to the nature of the cooperation or assistance requested), provided that EOS shall reimburse Servier of its internal costs and its expenses in relation with such assistance.

(g) Reimbursable Amount . In the event that Servier terminates this Agreement pursuant to Section 11.2 (Unilateral Termination by Servier), the Reimbursable Amount (if any such amount is outstanding) shall no longer be payable unless and until both of the following conditions are satisfied: (a) EOS requests the transfer of the Regulatory Materials pursuant to Section 11.6 (c) and (b) EOS, or any of its Affiliates or sublicensees file an MAA (or equivalent in the Retained Territory) or obtain the transfer in their name of a Regulatory Approval using the Regulatory Materials transferred by Servier. If the Reimbursable Amount becomes payable pursuant to the preceding sentence, it shall be paid as follows: Servier shall receive *** percent (***%) of all licensing proceeds received by EOS from a Third Party Partner or any other licensees or sublicensees of the Product anywhere in the world (including any upfront, milestone payments and royalties), until the Reimbursable Amount has been paid in full.

(h) Sole Remedy . In the event that Servier terminates this Agreement pursuant to Section 11.2 (Unilateral Termination by Servier) or EOS terminates this Agreement for Servier’s material breach of its obligations set forth in 3.6 and 5.4, the provisions set forth in Section 11.6 (c), (e) and/or (f) if elected by EOS shall constitute EOS’ sole remedy

11.7 Accrued Rights . Subject to Section 11.6 (h), termination or expiration of this Agreement for any reason shall be without prejudice to any right which shall have accrued to the benefit of either Party prior to such termination or expiration, including damages arising from any breach under this Agreement. Such termination or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement.

 

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11.8 Survival . Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. Notwithstanding anything to the contrary, the following provisions shall survive any expiration or termination of this Agreement: Sections 3.2(b), 3.7, 7.2, 7.5, 8.9, 9.1, 11.6(b), 11.6(g), 11.7, 11.8, 12.4 and Articles 1, 10, 13, 14 and 15.

 

12. REPRESENTATIONS AND WARRANTIES AND COVENANTS

12.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:

(a) Corporate Existence. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing, if applicable, under the Laws of the jurisdiction in which it is incorporated.

(b) Corporate Power, Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement, and to carry out and otherwise perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, and (iv) the carrying out and other performance of its obligations under this Agreement by such Party (a) does not conflict with, or contravene or constitute any default under, any agreement, instrument or understanding, oral or written, to which it is a party, including its certificate of incorporation or by-laws, and (b) does not violate applicable Law or any judgment, injunction, order or decree of any governmental authority having jurisdiction over it

(c) No government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements.

12.2 Additional Representations and Warranties of EOS . EOS represents and warrants to Servier that, as of the Effective Date:

(a) Title; Encumbrances . It has sufficient legal and/or beneficial title, ownership or license, free and clear from any mortgages, pledges, liens, security interests, conditional and installment sale agreements, encumbrances, charges or claims of any kind, of the EOS Technology to grant the licenses and lien to Servier as purported to be granted pursuant to this Agreement. EOS is the sole and exclusive owner of or exclusively Controls, pursuant to the Advenchen Agreement, all of the EOS Patents and EOS Know-How. EOS has the right to use and disclose and to enable Servier to use and disclose (in each case under appropriate conditions of confidentiality) the EOS Know-How. EOS has taken all reasonable precautions to preserve the confidentiality of the EOS Know-How, and has not disclosed to any Third Party any EOS Know-How that is or was confidential except under appropriate conditions of confidentiality.

 

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(b) Sufficiency . Exhibit 1.33 sets forth a complete and accurate list of all EOS Patents in existence as of the Effective Date. The EOS Patents are all of the Patents owned or Controlled by EOS or its Affiliates as of the Effective Date that claim the composition, manufacture or use of a Compound and/or Product.

(c) Non-Infringement . To EOS’ knowledge, none of the Development, Manufacture, or Commercialization of the Compound or Product as it exists as of the Effective Date, interferes with, infringes, misappropriates or otherwise violates any intellectual property rights of any Third Party. EOS has not received any verbal or written claim or demand of any person or entity that the manufacture, use, or sale of the Compound in the Licensed Territory infringes a Third Party Patent or infringes or misappropriates any other Third Party intellectual property.

(d) No Out-Bound Agreements . EOS has not granted any Third Party (including any academic organization or agency), or any Affiliate, any rights to the Compound or Product (except for rights outside of the Licensed Territory).

(e) Proper Assignment of Rights . EOS has obtained from all individuals who participated in any respect in the invention or authorship of any EOS Technology owned by EOS or its Affiliates effective assignments of all ownership rights of such individuals in such EOS Technology, either pursuant to written agreement or by operation of law.

(f) Pending or Threatened Proceedings . There are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving the Compound and/or the EOS Technology relating to the Compound by or against EOS or any of its Affiliates, , in or before any court, governmental or regulatory authority. In particular, there are no pending or threatened product liability actions involving the Compound. There are no claims, judgments or settlements against or owed by EOS relating to the EOS Technology or the Compound.

(g) Intellectual Property Proceedings. EOS is not aware of any fact or circumstance which would make the EOS Patents invalid and enforceable. Neither EOS nor any of its Affiliates have received any written communication alleging that any of the EOS Patents are unpatentable, invalid or unenforceable or are subject to interference, reexamination, reissue, revocation, opposition, appeal or other administrative proceeding. EOS has not taken any action or failed to take any action, which action or failure reasonably could be expected to result in the abandonment, cancellation, forfeiture, relinquishment, invalidation or unenforceability of any of the EOS Patents. As of the Effective Date, the EOS Patents exist, and EOS has not received any written notice from a Government Authority that the EOS Patents are invalid or unenforceable, in whole or in part.

(h) Information and Regulatory Data. EOS has disclosed or made available to Servier in writing, complete and correct copies of (i) any and all study reports, data and information in its Control or that been provided to any Regulatory Authority, (ii) all filings and

 

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correspondence between EOS and its Affiliates and any Regulatory Authority, in the case of both (i) and (ii) relating to the Compound, and any other Information requested by Servier in writing. In the course of the development of Products, each Party has not used any employee or consultant who has been debarred by any Regulatory Authority, or, to the Best Knowledge of EOS, was the subject of debarment proceedings by a Regulatory Authority. All studies conducted with respect to the Compound have been conducted by EOS, and to EOS’ Best Knowledge, Advenchen, substantially in accordance with applicable Laws by persons with appropriate education, knowledge and experience.

(i) Due Diligence Data. The documents containing the technical Information and Know-How disclosed or made available to Servier prior to the Effective Date are true and accurate copies of what they purport to be. EOS has made available to Servier all Information in its (or its Affiliates’) possession or control relating to the Compound and the Development, Manufacture and Commercialization of the Compound or the Product, that EOS believes, after due inquiry, is material to the marketability of the Product in the Licensed Territory. In addition, EOS has disclosed to Servier any material information known to EOS as of such date with respect to (i) the safety of the Compound, (ii) the efficacy of such Compound, and (iii) any then existing circumstance which would be reasonably likely to prohibit or prevent the Development, Manufacturing and/or Commercialization of the Compound in the Licensed Territory.

(j) Notice of Infringement or Misappropriation. Neither EOS nor its Affiliates have received any written notice from any Third Party asserting or alleging that any research or development of the Compound or Product by EOS or its Affiliates prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party.

(k) Advenchen Agreement . EOS is not, and has not received any written notice from Advenchen alleging otherwise, in default or in breach of the Advenchen Agreement. There exists no condition or event (including the execution, delivery and performance of this Agreement) which, with the giving of notice or the lapse of time or both, would constitute a default by EOS under the Advenchen Agreement, or would give Advenchen any right of termination, cancellation or acceleration of any performance under any such agreement or result in the creation or imposition of any lien, in each case. EOS shall be solely responsible for any and all payments that become due to Advenchen, and EOS promptly shall make all such payments.

12.3 Mutual Covenants .

(a) No Debarment. In the course of the Development of Products, neither Party nor its Affiliates shall use any employee or consultant who is debarred by any Regulatory Authority, or, to such Party’s Best Knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its Affiliates’ employees or consultants has been debarred or is the subject of debarment proceedings by any Regulatory Authority.

(b) Compliance. Each Party and its Affiliates shall comply in all material respects with all applicable Laws in the Development, Manufacture and Commercialization of the Product and performance of its obligations under this Agreement.

 

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12.4 Disclaimer . EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. EOS understands and acknowledges, on behalf of itself, Affiliates and sublicensees, that access to and use of any pre-clinical and clinical data or any other Information disclosed by Servier, its Affiliates or sublicensees under this Agreement, are disclosed on an “as is” basis without any warranty of any kind. EOS, its Affiliates and sublicensees, accept all risk and liability in relation to the use of such data or Information. Servier understands and acknowledges, on behalf of itself, Affiliates and licensees, that the Third Party Partner to the extent such Third Party Partner is not an Affiliate of EOS makes no warranty of any kind to Servier as to the pre-clinical and clinical data or any other Information of such Third Party Partner and made available to Servier under this Agreement.

 

13. INDEMNIFICATION AND LIMITATION OF LIABILITY

13.1 Indemnification by Servier. Servier shall defend, indemnify, and hold EOS and its Affiliates and their respective officers, directors, employees, and agents (the “ EOS Indemnitees ”) harmless from any and all damages or other amounts payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such EOS Indemnitees, all to the extent resulting from claims, suits, proceedings or causes of action brought by such Third Party (“ Claims ”) against such EOS Indemnitees to the extent arising from or based upon (a) the Development, Manufacture or Commercialization of the Product by or on behalf of Servier or its Affiliates or its or their sublicensees (excluding in all cases EOS or its Affiliates or sublicensees) in the Licensed Territory; (b) the breach of any of Servier’s obligations under this Agreement, including Servier’s representations and warranties set forth herein; or (c) the willful misconduct or gross negligence of any Servier Indemnitee.

13.2 Indemnification by EOS . EOS shall defend, indemnify, and hold Servier and its Affiliates and their respective officers, directors, employees, and agents (the “Servier Indemnitees” ) harmless from and against any and all damages or other amounts payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Servier Indemnitees, all to the extent resulting from Claims against such Servier Indemnitees to the extent arising from or based upon (a) the Development, Manufacture or Commercialization of the Product by or on behalf of EOS or its Affiliates or its or their sublicensees (excluding in all cases Servier, its Affiliates or its sublicensees) prior to the Effective Date or in the Retained Territory after the Effective Date; (b) the breach of any of EOS’ obligations under this Agreement, including EOS’ representations and warranties set forth herein; (c) the willful misconduct or gross negligence of any EOS Indemnitee; or (d) the use by EOS or its Affiliates or its or their sublicensees (including any Third Party Partner) in the Retained Territory of pre-clinical and clinical data and Information or Regulatory Materials supplied by Servier to EOS under this Agreement.

 

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13.3 Conditions to Indemnification. The Party claiming indemnity under this Article 13 (the “ Indemnified Party ”) shall give written notice to the Party from whom indemnity is being sought (the “ Indemnifying Party ”) promptly after learning of such Claim, provided that the failure to promptly provide such notice shall not relieve the Indemnifying Party of any of its indemnification obligations hereunder except to the extent that the Indemnifying Party’s defense of the relevant Claim is prejudiced by such failure. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, that, as long as however that (a) the claim solely seeks monetary damages, (b) the Indemnifying Party expressly agrees in writing that as between the Indemnifying Party and the Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy and discharge the claim in full and (c) the Indemnifying Party provides evidence to the Indemnified Party’s satisfaction that it has the financial capacity to defend and indemnify the Indemnified Party against the Claim (the matters described in (a), (b) and (c), the “ Litigation Conditions ”), the Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld. So long as the Litigation Conditions are satisfied and the Indemnifying Party is actively defending the Claim in good faith, the Indemnified Party shall not settle or compromise any such Claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the Indemnified Party may defend against, consent to the entry of any judgment, or enter into any settlement with respect to such Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article 13.

13.4 Limitation of Liability.

(a) EXCEPT FOR ANY CLAIMS RELATED TO ONE PARTY’S INFRINGEMENT OF THE OTHER PARTY’S INTELLECTUAL PROPERTY OUTSIDE OF THE RIGHTS AND LICENSES GRANTED HEREUNDER, AND/OR ANY BREACH OF CONFIDENTIALITY OR AMOUNTS PAYABLE TO A THIRD PARTY CLAIMANT UNDER SECTIONS 13.1 OR 13.2, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

(b) EOS AGREES AND ACKNOWLEDGES, AND ACCEPTS ALL RISK AND LIABILITY, ON BEHALF OF ITSELF, ITS AFFILIATES AND ITS SUBLICENSEES, IN RELATION TO THE USE OF ANY PRE-CLINICAL AND CLINICAL DATA OR INFORMATION DISCLOSED BY SERVIER UNDER THIS AGREEMENT, AND THAT SERVIER SHALL NOT BE LIABLE FOR ANY DAMAGES WHATSOEVER RELATED TO THE USE OF ANY SUCH DATA OR INFORMATION BY EOS, ITS AFFILIATES AND ITS AND THEIR SUBLICENSEES. SERVIER AGREES AND ACKNOWLEDGES THAT THE THIRD PARTY PARTNER TO THE EXTENT SUCH THIRD PARTY PARTNER IS NOT AN

 

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AFFILIATE OF EOS SHALL NOT BE LIABLE FOR ANY DAMAGES WHATSOEVER RELATED TO THE USE BY SERVIER, ITS AFFILIATES OR LICENSEES OF ANY DATA OR INFORMATION OF SUCH THIRD PARTY PARTNER AND MADE AVAILABLE TO SERVIER UNDER THIS AGREEMENT.

(c) THE LIMITATIONS OF LIABILITY CONTAINED IN THIS AGREEMENT ARE A FUNDAMENTAL PART OF THE BASIS OF EACH PARTY’S BARGAIN HEREUNDER, AND NEITHER PARTY WOULD ENTER INTO THIS AGREEMENT ABSENT SUCH LIMITATION OF LIABILITY.

13.5 Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, non-renewal or material changes in such insurance. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 13.

 

14. D ISPUTE R ESOLUTION .

14.1 Disputes . The Parties recognize that disputes as to certain matters may from time to time arise that relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 14 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

14.2 Binding Arbitration. If the JEC is unable to resolve a given dispute referred to it pursuant to Section 2.8(b) within thirty (30) days following such referral of such dispute to the JEC, except for any Non-Arbitrable Disputes, either Party may have the given dispute settled by binding arbitration administered by the International Chamber of Commerce (“ ICC ”) pursuant to its Dispute Resolution Rules then in effect, and judgment on the arbitration award may be entered in any court having jurisdiction thereof. The Parties agree that:

(a) The place of arbitration shall be Geneva, Switzerland and all proceedings and communications shall be in English.

(b) Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damage. Except to the extent necessary to confirm an award or as may be required by applicable Laws, neither Party nor any arbitrator may

 

50


disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations.

14.3 Non-Arbitrable Disputes . Any dispute with respect to which a Party has final decision-making authority pursuant to Section 2.8 or other provisions of this Agreement, or any dispute between the Parties to the extent relating to the validity, scope, enforceability, inventorship, or ownership of intellectual property rights (each, a “ Non-Arbitrable Dispute ”), shall not be subject to resolution by binding arbitration under Section 14.2 and instead shall be resolved in a court or governmental agency of competent jurisdiction located in Switzerland.

 

15. MISCELLANEOUS

15.1 Entire Agreement; Amendments . This Agreement, including all Exhibits attached hereto as well the Clinical Supply Agreement, Quality Agreement, Safety Data Exchange Agreement when entered into, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

15.2 Rights in Bankruptcy . All rights and licenses granted under or pursuant to any section of this Agreement are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the “ Bankruptcy Code ”), licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code. The Parties will retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code. Each Party agrees that the other Party, as licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code or any other provisions of applicable Law outside the United States that provide similar protection for “intellectual property.” The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the U.S. Bankruptcy Code or analogous provisions of applicable Law outside the United States, the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in such Party’s possession, will be promptly delivered to it upon such Party’s written request thereof. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code.

15.3 Force Majeure . Each Party shall be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by force majeure (as defined below) and the nonperforming Party promptly provides notice of the

 

51


prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, “ force majeure ” shall include conditions beyond the control of the Parties, including an act of God, war, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe.

15.4 Notices . Any notices given under this Agreement shall be in writing, addressed to the Parties at the following addresses, and delivered by person, by facsimile (with receipt confirmation), or by FedEx or other reputable courier service. Any such notice shall be deemed to have been given: (a) as of the day of personal delivery; (b) one (1) day after the date sent by facsimile service; or (c) on the day of successful delivery to the other Party confirmed by the courier service. Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below. In the event of conflicting notices from Les Laboratoires Servier and Institut de Recherches Internationales Servier, the notice of Les Laboratoires Servier shall prevail.

 

If to EOS:    ETHICAL ONCOLOGY SCIENCE S.P.A.
   Via Monte di Pietá, 1/A, 20121
   Milan, Italy
   Attention : Chief Executive Officer
   FAX : + 39.02.87.39.16.17
with copy to :    Michael J. Kennedy, Esq.
   Shearman & Sterling
   San Francisco, CA
If to Servier:    LES LABORATOIRES SERVIER
   50 rue Carnot
   92284 Suresnes Cedex
   France
   Attention: Direction de la Coopération Scientifique
   FAX : +33.1.55.72.39.00
with copy to :    LES LABORATOIRES SERVIER
   50 rue Carnot
   92284 Suresnes Cedex
   France
   Attention: Direction Juridique
   FAX : +33.1.55.72.39.00

15.5 Assignment . Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that Servier may make such an assignment without EOS’ consent to an Affiliate (which shall not relieve Servier of its obligations hereunder), and that either Party may make such an assignment without the other Party’s consent to a Third Party successor to substantially all of the business of such Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other

 

52


transaction. Any successor or assignee of rights and/or obligations permitted hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 15.5 shall be null, void and of no legal effect.

15.6 Performance by Affiliates . Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

15.7 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

15.8 Severability . If any of the provisions of this Agreement are held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

15.9 No Waiver . Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time.

15.10 Independent Contractors . Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

15.11 Governing Law . Resolution of all disputes, controversies or claims arising out of, relating to or in connection with this Agreement or the performance, enforcement, breach or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of Switzerland, without regard to conflicts of law rules.

15.12 Communications with Internal Counsel . In the course of the negotiation and implementation of this Agreement and the resolution of any disputes, investigations, administrative or other proceedings relating thereto, Servier will call upon the members of its internal legal department to provide advice to Servier and its directors, employees and agents on legal matters. Notwithstanding any rights to the contrary under applicable procedural or substantive rules of law, EOS agrees not to request, produce or otherwise use any such

 

53


communications between members of the Servier legal department and Servier directors, employees or agents in connection with any such disputes, investigations, administrative or other proceedings, to the extent such communications, if they had been exchanged between Servier and external attorneys, would have been covered by legal privilege and not discloseable.

15.13 Construction of this Agreement . Except where the context otherwise requires, wherever used, the use of any gender shall be applicable to all genders, and the word “ or ” is used in the inclusive sense. When used in this Agreement, “ including ” means “ including without limitation ”. References to either Party include the successors and permitted assigns of that Party. The headings of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The Parties have each consulted counsel of their choice regarding this Agreement and have jointly prepared this Agreement, and, accordingly, no provisions of this Agreement shall be construed against either Party on the basis that the Party drafted this Agreement or any provision thereof. If the terms of this Agreement conflict with the terms of any Exhibit, then the terms of this Agreement shall govern. The official text of this Agreement and any Exhibits hereto, any notice given or accounts or statements required by this Agreement, and any dispute proceeding related to or arising hereunder, shall be in English. In the event of any dispute concerning the construction or meaning of this Agreement, reference shall be made only to this Agreement as written in English and not to any other translation into any other language.

15.14 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be an original and all of which shall constitute together the same document. Counterparts may be signed and delivered by facsimile, or electronically in PDF format, each of which shall be binding when sent.

[Signature page follows.]

 

54


I N W ITNESS W HEREOF , the Parties have executed this Agreement in duplicate originals by their proper officers as of the Effective Date.

 

L ES L ABORATOIRES S ERVIER   E THICAL O NCOLOGY S CIENCE S.P.A.
By:  

/s/ Dr Jean-Philippe Seta

  By:  

/s/ Mr. Silvano Spinelli

Name:   Dr Jean-Philippe SETA   Name:   Mr. Silvano SPINELLI
Title:   Proxy   Title:   Chief Executive Officer
By:  

/s/ Mr. Christian Bazantay

   
Name:   Mr. Christian BAZANTAY    
Title:   Proxy    
I NSTITUT DE R ECHERCHES I NTERNATIONALES S ERVIER    
By:  

/s/ Dr. Emmanuel Canet

   
Name:   Dr. Emmanuel CANET    
Title:   President R&D    


List of Exhibits and Schedules

 

Exhibit 1.18    E-3810
Exhibit 1.32    EOS Know-How
Exhibit 1.33    EOS Patents
Exhibit 1.43    FTE Rate
Exhibit 3.2    Initial version of the Global Development Plan
Schedule 7.4 (c)    ADBK Actions


Exhibit 1.18

E-3810

The compound 6-({7-[(1-aminocyclopropyl)methoxy]-6-methoxyquinolin-4-yl}oxy)-

N-methylnaphthalene-1-carboxamide of formula (I):

 

 

LOGO

and its pharmaceutically acceptable salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives.


Exhibit 1.32

EOS Know-How

 

1. All Advenchen know how licensed to EOS pursuant to the “ Advenchen Agreement

 

2. Copies of all file histories and related documentation (including attorney files) for the Patents identified in Exhibit 1.33 .

 

3. Description of the synthetic procedures explored by EOS during the process optimization for the preparation of the Compound and conclusions summarizing the rationale for the selection of the current GMP process.

 

4. All reports of CMC studies Controlled by EOS relevant to the Compound (API and FP) . This includes without limitation the characterization of impurities, polymorphism studies and salt screening.

 

5. Description of the analytical methods Controlled by EOS including all protocols and reports.

 

6. All specifications, executed batch records and certificates of analysis, as applicable, for batches of Compound (API and FP) manufactured by EOS’ designees

 

7. All protocols and results of stability studies conducted on the Compound (API and FP) by EOS’ designees

 

8. In general, all Information Controlled by EOS that may be reasonably required for transferring the GMP manufacturing of API and FP to another manufacturing site.

 

9. Protocols and Reports (or summary results for non GLP pharmacology experiments) of the non clinical pharmacology, safety, toxicology and pharmacokinetics studies Controlled by EOS.

 

10. IMPD of E-3810 (all versions)

 

11. Trial Master File (TMF) of the clinical study E-3810-I-01. Of note, the study is ongoing at the Effective Date and the complete TMF will be available later during the Term.

 

12. Electronic CRFs and Database of the of the clinical study E-3810-I-01 (to be completed during the Term)

 

13. In general, all Information Controlled by EOS that may be reasonably required for continuing the clinical development of the Compound.


Exhibit 1.33

EOS Patents

Patent Family EOS005

 

Assignee:    Advenchen Laboratories LLC
Title:    SPIRO SUBSTITUTED COMPOUNDS AS ANGIOGENESIS INHIBITORS
Priority Date(s):    14 March 2007, 4 June 2007, 23 February 2008
Priority App(s) :    US Provisional Application No. 60/894,693 filed 14 March 2007;
   US Provisional Application No. 60/941,699 filed 4 June 2007;
   US Patent Application No. 12/036,245 filed 23 February 2008

 

Country

  

Application No.

   Filing
Date
  

Serial/Grant/

Reg. No.

   Issue Date/
Publ. Date
PCT    PCT/US08/054817    24/02/08    WO 2008/112408 A1    Publ. 18/09/08
Australia    2008226667    11/09/09      
Brazil    PI0808764-4    11/09/09      
Canada    2,681,005    11/09/09    CA 2,681,005 A1    Publ. 18/09/08
Europe    08730590.0    22/09/09    EP 2125777 A1    Publ. 02/12/09
India    3236/KOLNP/2009    11/09/09      
Israel    200854    10/09/09      
Mexico    MX/a/2009/009843    11/09/09    MX 2009009843 A    Publ. 28/10/09
New Zealand    579619    11/09/09    579619    09/07/12
South Korea    2009-7019020    11/09/09    09-120483    Publ. 24/11/09


Patent Family EOS004

 

Assignee:    EOS ETHICAL ONCOLOGY SCIENCE S.p.A.
Title:    A PROCESS FOR THE PREPARATION OF 6-(7-((1-AMINOCYCLOPROPYL)METHOXY)-6-METHOXYQUINOLIN-4-YLOXY)-N-METHYL-1-NAPHTHAMIDE AND SYNTHETIC INTERMEDIATES THEREOF
Priority Date(s):    16 March 2009
Priority App(s) :    Italian Patent Application No. MI2009A000397

 

Country

   Application No.    Filing
Date
     Serial/Grant/
Reg. No.
   Issue Date/
Publ. Date

China*

   201080011948.7      15/09/11       CN 102356063A    Publ. 15/02/12

Europe

   10712320.0      05/08/11       EP2408739 A1    Publ. 25/01/12

Italy

   MI2009A000397      16/03/09       1393351    20/04/12

PCT

   PCT/EP2010/001519      11/03/10       WO 2010/105761A1    Publ. 23/09/10


Exhibit 1.43

FTE Rate

FTE Rate is fixed at an initial rate of *** Euro (€***) per FTE per Calendar Year. Unless otherwise agreed between the Parties, the FTE Rate shall be changed annually on a Calendar Year basis to reflect any year-to-year percentage increase or decrease (as the case may be) in the Consumer Price Index in France of INSEE (“ CPI ”). The first revision of such FTE Rate shall take place on January 1st, 2014.


Exhibit 3.2

Initial version of the Global Development Plan

 

***


Schedule 7.4 (c)

ADBK Actions

Schedule 7.4 (c) - ADBK Actions

Advenchen will either (i) transfer all Patent (existing and future) rights licensed to EOS under the existing Advenchen/ EOS license (the “ License Agreement ”) in EOS’ licensed territory (the “ EOS Licensed Patents ”) to a newly formed entity or (ii) transfer out of Advenchen to a entity not a subsidiary of Advenchen all such Patent rights that are not EOS Licensed Patents. Such reorganized entity under either subclause (i) or (ii) is referred to as the “Ongoing Entity”. In each case, Advenchen shall represent it has no activity or liability other than as permitted below and otherwise satisfies the conditions stated below.

The organizational documents of the Ongoing Entity (whether structured as a limited liability Ongoing Entity, partnership, corporation or otherwise, the “ Charter Documents ”) shall contain the following provisions: 1

 

  1. The Ongoing Entity’s sole business and activity shall be to hold the EOS Licensed Patents and other intellectual property licensed to EOS and to perform its obligations and exercise its rights under the License Agreement;

 

  2. The Ongoing Entity shall not transfer or otherwise license any assets of the Ongoing Entity except as, and to the extent, contemplated by the License Documents;

 

  3. The Ongoing Entity shall not, to the fullest extent permitted by law, engage in any dissolution, liquidation, consolidation, merger, asset sale or transfer of ownership interests other than any asset sale or transfer of ownership interests in the ordinary course of its business;

 

  4. The Ongoing Entity shall not (a) borrow money and issue evidences of indebtedness or secure the same by mortgage, pledge, letter of credit, or other lien on any assets of the Ongoing Entity, unless the creditor or holder thereof expressly agrees that upon the exercise of any of its rights or remedies all rights and remedies of EOS under the License Agreement will be unaffected and that such holder will not institute a bankruptcy proceeding against the Ongoing Entity or join in any petition seeking the same or (b) grant any guarantee, become obligated for or pay the debts of any person or hold the credit of the Ongoing Entity out as being available to satisfy the obligations of any other person (nor indemnify any person for losses resulting therefrom), or hold the Ongoing Entity out as responsible for the debts of any other person or for the decisions or actions with respect to the business and affairs of any other person, nor seek or obtain credit or incur any obligation to any third party based upon the creditworthiness or assets of any other person (i.e., other than based on the creditworthiness or assets of the Ongoing Entity) nor allow any person to do such things based on the credit of the Ongoing Entity;

 

  5. The Ongoing Entity shall at all times remain solvent and pay its debts and liabilities from its assets as the same shall become due;

 

  6. The Ongoing Entity shall not form, or cause to be formed, any subsidiaries;

 

1   For ease of exposition, the remainder of this Schedule 7.4 (c) assumes that the Ongoing Entity is structured as a limited liability company.


  7. The Ongoing Entity shall deposit any funds or payments received under the Agreement into a bank account only in the Ongoing Entity’s name and under its control. The Ongoing Entity shall maintain accurate records, books of account and financial statements disclosing that its assets are not available to pay creditors of any of its affiliates;

 

  8. The Ongoing Entity shall file its own tax returns, if any, as may be required under applicable law, to the extent (1) not part of a consolidated group filing a consolidated return or returns or (2) not treated as a division for tax purposes of another taxpayer, and shall pay any taxes so required to be paid under applicable law.

 

  9. The directors shall hold appropriate meetings to authorize all of the Ongoing Entity’s corporate actions, which meetings may be held by telephone conference call;

 

  10. The Ongoing Entity shall pay its own liabilities and expenses out of its own funds as the same shall become due;

 

  11. The Ongoing Entity shall hold itself out as a separate legal entity;

 

  12. The Ongoing Entity shall maintain its valid existence under the laws of the [State of Delaware], and take reasonable efforts to remain in good standing;

 

  13. The Ongoing Entity shall have its own directors, including an Independent Director at all times who will be appointed by EOS as a member of the Board of Directors of the Ongoing Entity. The Independent Director can only be removed or replaced by EOS. In addition, the Ongoing Entity shall create a special membership interest and issue such interest (the “ Special Interest ”) to EOS. The Special Interest shall not be redeemable, but shall have no economic, informational, voting or other rights, except for the voting rights specified below;

 

  14. The Ongoing Entity shall act solely in its corporate name and through its duly authorized directors, officers or agents in the conduct of its business, and shall conduct its business so as not to mislead others as to the identity of the entity or assets with which they are concerned. Without limiting the generality of the foregoing, all written and oral communications, including without limitation letters, invoices, purchase orders, contracts, statements and loan applications, shall be made solely in the Ongoing Entity’s own name;

 

  15. The Ongoing Entity shall direct creditors of the Ongoing Entity to send invoices and other statements of account of the Ongoing Entity directly to the Ongoing Entity and not to any affiliate and cause the affiliates to direct their creditors not to send invoices and other statements of accounts of such affiliate to the Ongoing Entity;

 

  16. The Ongoing Entity shall pay from its own bank accounts for accounting and payroll services, rent, lease and other expenses (or the Ongoing Entity’s allocable share of any such amounts provided by one or more other affiliates) and not have such operating expenses (or the Ongoing Entity’s allocable share thereof) paid by any affiliate;

 

  17. The Ongoing Entity’s resolutions, agreements and other instruments shall be maintained by it as official records, separately identified and held apart from the records of any affiliate;

 

  18. The Ongoing Entity shall grant a first priority lien on the EOS Patents that it holds in order to secure EOS’ damages in the event that the License Agreement is terminated other than for EOS’s breach and EOS’ rights and licenses under such EOS Patents are not maintained.

 

11


Notwithstanding any other provision that otherwise so empowers the Ongoing Entity, any member of the Ongoing Entity (other than the Special Member), the Board, any Officer or any other Person, neither the members nor the Board nor any Officer nor any other Person shall be authorized or empowered, nor shall they permit the Ongoing Entity, without the prior unanimous written consent of the Special Member and the Board (including the Independent Director), to modify the Charter Documents or take any Material Action, provided, however, that the Board may not vote on, or authorize the taking of, any Material Action, unless there is the Independent Director then serving in such capacity and it has given such Independent Director and the Special Member at least 30 days prior notice thereof. For purposes of the foregoing, “ Material Action ” means to consolidate or merge the Ongoing Entity with or into any Person, or sell all or substantially all of the assets of the Ongoing Entity (other than to a Qualifying Person), or to institute proceedings to have the Ongoing Entity be adjudicated bankrupt or insolvent, or consent to the institution of bankruptcy or insolvency proceedings against the Ongoing Entity or file a petition seeking, or consent to, reorganization or relief with respect to the Ongoing Entity under any applicable federal or state law relating to bankruptcy, or consent to the appointment of a receiver, liquidator, assignee, trustee, sequestrator (or other similar official) of the Ongoing Entity or a substantial part of its property, or make any assignment for the benefit of creditors of the Ongoing Entity, or admit in writing the Ongoing Entity’s inability to pay its debts generally as they become due, or take action in furtherance of any such action, or, to the fullest extent permitted by law, dissolve or liquidate the Ongoing Entity. For the purposes hereof, a “ Qualifying Person ” means any Person that has expressly affirmed all of EOS and its sublicensees’ right under the License Agreement and that has instituted, with respect to the EOS Licensed Patents the procedures specified herein prior to any merger with or transfer to such person and any pharmaceutical company with gross revenue in excess of $500,000,000.

The Independent Director shall not have any fiduciary duties to the members, any Director or any other Person; provided, however, the foregoing shall not eliminate the implied contractual covenant of good faith and fair dealing. To the fullest extent permitted by law,[ including Section 18-1101(e) of the Act], an Independent Director shall not be liable to the Ongoing Entity, the members or any other Person bound by the Charter Documents for breach of contract or breach of duties (including fiduciary duties), unless the Independent Director acted in bad faith or engaged in willful misconduct. All right, power and authority of the Independent Director shall be limited to the extent necessary to exercise those rights and perform those duties specifically set forth herein. No Independent Director shall at any time serve as trustee in bankruptcy for any Affiliate of the Ongoing Entity. Notwithstanding any other provision of this Agreement, the bankruptcy of a member shall not cause such member to cease to be a member of the Ongoing Entity and upon the occurrence of such an event, the Ongoing Entity shall continue without dissolution.

 

12

Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

The Board of Directors

EOS S.p.A.:

We consent to the incorporation by reference in this Form 8-K of Clovis Oncology, Inc. filed with the Securities and Exchange Commission on November 19, 2013 and the Registration Statements (Form S-3 Nos. 333-188063 and 333-189234 and Form S-8 Nos. 333-178283, 333-182278 and 333-190565) of Clovis Oncology, Inc. of our report dated November 19, 2013, with respect to the balance sheets of EOS S.p.A. as of December 31, 2012 and 2011, and the related statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2012, which report appears in the Form 8-K of Clovis Oncology, Inc. dated November 19, 2013.

/s/ KPMG S.p.A.

Milan, Italy

November 19, 2013

Exhibit 99.1

Report of Independent Registered Public Accounting Firm

The Board of Directors

EOS S.p.A.

We have audited the accompanying balance sheets of EOS S.p.A. as of December 31, 2012 and 2011, and the related statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2012. These financial statements are the responsibility of the company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of EOS S.p.A. as of December 31, 2012 and 2011, and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2012, in conformity with generally accepted accounting principles in Italy.

As discussed in Note 14 to the financial statements, accounting principles generally accepted in Italy vary in certain significant respects from U.S. generally accepted accounting principles.

/s/ KPMG S.p.A.

Milan, Italy

November 19, 2013


EOS S.p.A.

Balance Sheets

(Amounts in Euro)

 

     September 30,     December 31,  
     2013     2012      2011  
     (Consolidated &
Unaudited)
              
ASSETS        

Current Assets:

       

Cash and cash equivalents

   3,655,138      39,886,291       762,563   

Accounts receivable, net

     2,017,868        1,049,154         68,036   

Tax receivables

     1,660,906        1,661,260         —     

Other current receivables

     1,178,560        1,213,719         1,095,596   

Other current assets

     69,973        192,880         25,704   
  

 

 

   

 

 

    

 

 

 

Total Current Assets

     8,582,445        44,003,304         1,951,899   

Fixed Assets

       

Intangible fixed assets

     92,318        92,439         300,717   

Other long term assets

     17,387        56,168         51,699   
  

 

 

   

 

 

    

 

 

 

Total Fixed Assets

     109,705        148,607         352,416   
  

 

 

   

 

 

    

 

 

 

Total Assets

   8,692,150      44,151,911       2,304,315   
LIABILITIES AND SHAREHOLDERS’ EQUITY        

Current Liabilities:

       

Amounts due Advenchen Laboratories LLC

   —        12,386,880       —     

Accounts payable

     1,528,000        1,732,725         972,744   

Taxes payable

     46,011        1,546,194         44,262   

Other current liabilities

     279,888        213,847         200,605   
  

 

 

   

 

 

    

 

 

 

Total Current Liabilities

     1,853,899        15,879,646         1,217,611   

Long Term Liabilities

     1,540,000        1,540,000         —     
  

 

 

   

 

 

    

 

 

 

Total Liabilities

     3,393,899        17,419,646         1,217,611   

Shareholders’ Equity

       

Share capital

     1,244,344        1,244,344         1,029,449   

Share premium reserve

     3,342,376        3,342,376         6,184,315   

Legal reserves

     248,869        —           —     

Other reserves

     1,996,675        —           2,989,346   

Retain earnings (losses) carried forward

     —          —           (4,412,686

Net profit (loss) for the year

     (1,534,013     22,145,545         (4,703,720
  

 

 

   

 

 

    

 

 

 

Total Shareholders’ Equity

     5,298,251        26,732,265         1,086,704   
  

 

 

   

 

 

    

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

   8,692,150      44,151,911       2,304,315   
  

 

 

   

 

 

    

 

 

 

See accompanying notes


EOS S.p.A.

Statements of Operations

(Amounts in Euro)

 

     For the Year Ended December 31,  
     2012      2011     2010  

Revenues

       

License fees

   45,000,000       —        —     

Other revenues

     1,139,009         86,015        331,067   
  

 

 

    

 

 

   

 

 

 

Total revenues

     46,139,009         86,015        331,067   

Operating Expenses

       

License fees

     12,948,613         —          —     

Research and development

     6,934,164         4,224,542        4,293,998   

General and administrative

     2,622,013         554,221        487,461   
  

 

 

    

 

 

   

 

 

 

Total operating expenses

     22,504,790         4,778,763        4,781,459   
  

 

 

    

 

 

   

 

 

 

Operating Income (Loss)

     23,634,219         (4,692,748     (4,450,392

Other income (expense), net

     181,276         (10,972     (36,121
  

 

 

    

 

 

   

 

 

 

Income (Loss) Before Income Taxes

     23,815,495         (4,703,720     (4,486,513

Income Tax Expense

     1,669,950         —          —     
  

 

 

    

 

 

   

 

 

 

Net Income (Loss)

   22,145,545       (4,703,720   (4,486,513
  

 

 

    

 

 

   

 

 

 

See accompanying notes


EOS S.p.A.

Statements of Operations

(Amounts in Euro)

 

     Nine Months Ended September 30,  
     2013     2012  
     (Consolidated & Unaudited)     (Unaudited)  

Revenues

    

License fees

   —        45,045,600   

Other revenues

     2,425,011        477,616   
  

 

 

   

 

 

 

Total revenues

     2,425,011        45,523,216   

Operating Expenses

    

License fees

     —          12,948,593   

Research and development

     2,637,691        5,171,617   

General and administrative

     1,373,568        2,412,675   
  

 

 

   

 

 

 

Total operating expenses

     4,011,259        20,532,885   
  

 

 

   

 

 

 

Operating Income (Loss)

     (1,586,248     24,990,331   

Other income (expense), net

     52,235        (5,545
  

 

 

   

 

 

 

Income (Loss) Before Income Taxes

     (1,534,013     24,984,786   

Income Tax Expense

     —          2,037,107   
  

 

 

   

 

 

 

Net Income (Loss)

   (1,534,013   22,947,679   
  

 

 

   

 

 

 

See accompanying notes


EOS S.p.A.

Statement of Stockholders’ Equity

(Amounts in Euro)

 

    Share Capital     Share
Premium
Reserve
    Legal
Reserve
    Capital
Injections
    Capital
Injections
for future
capital
increases
    Other
Reserves
    Retained
earnings (loss)
carried
forward
    Net income
(loss) for the
year
    Total
Stockholders’
Equity
 

Balance at December 31, 2009

  716,492      8,179,104      —        1,174,455      1,814,891      —        (4,412,686   (4,803,310   2,668,946   

Capital injection for future capital increases

    —          —          —          —          1,954,005        —          —          —          1,954,005   

Coverage of 2009 net loss

    —          (4,803,310     —          —          —          —          —          4,803,310        —     

Share capital increase subscribed February 2010

    152,200        3,547,781        —          —          —          —          —          —          3,699,981   

Net loss

    —          —          —          —          —          —          —          (4,486,513     (4,486,513
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2010

    868,692        6,923,575        —          1,174,455        3,768,896        —          (4,412,686     (4,486,513     3,836,419   

Capital injection for future capital increases

    —          —          —          —          1,954,005        —          —          —          1,954,005   

Coverage of 2010 net loss

    —          (4,486,513     —          —          —          —          —          4,486,513        —     

Share capital increase subscribed 22 December 2011

    160,757        3,747,253        —          1,814,891        (5,722,901     —          —          —          —     

Net loss

    —          —          —          —          —          —          —          (4,703,720     (4,703,720
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2011

    1,029,449        6,184,315        —          2,989,346        —          —          (4,412,686     (4,703,720     1,086,704   

Coverage of 2011 net loss

    —          (4,703,720     —          —          —          —          —          4,703,720        —     

Coverage of losses carryforward

    —          (1,423,340     —          (2,989,346     —          —          4,412,686        —          —     

Capital injection for future capital increases

    —          —          —          —          2,000,000        —          —          —          2,000,000   

Proceeds from issue of share capital

    136,880        3,285,121        —          —          (2,000,000     —          —          —          1,422,001   

Share capital increase from stock option exercise

    78,015        —          —          —          —          —          —          —          78,015   

Net income

    —          —          —          —          —          —          —          22,145,545        22,145,545   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2012

    1,244,344        3,342,376        —          —          —          —          —          22,145,545        26,732,265   

Legal reserve (Consolidated & Unaudited)

    —          —          248,869        —          —          —          —          (248,869     —     

Dividend distribution (Consolidated & Unaudited)

    —          —          —          —          —          —          —          (19,900,001     (19,900,001

Allocation of 2012 net income to other reserves (Consolidated & Unaudited)

    —          —          —          —          —          1,996,675        —          (1,996,675     —     

Net loss (Consolidated & Unaudited)

    —          —          —          —          —          —          —          (1,534,013     (1,534,013
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2013 (Consolidated & Unaudited)

  1,244,344      3,342,376      248,869      —        —        1,996,675      —        (1,534,013   5,298,251   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes


EOS S.p.A.

Statements of Cash Flows

(Amounts in Euro)

 

     Year Ended December 31,     Nine Months Ended September 30,  
     2012     2011     2010     2013     2012  
                       (Consolidated & Unaudited)     (Unaudited)  

Operating activities

          

Net income (loss)

   22,145,545      (4,703,720   (4,486,513   (1,534,013   22,947,679   

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

          

Amortization and depreciation

     237,773        260,814        272,713        32,389        177,874   

Change in employees’ leaving entitlement

     (10,813     1,349        1,281        25        1,138   

Change in receivables

     (2,760,501     374,415        (142,596     (907,966     (45,433,198

Change in other current assets

     (167,176     17,369        11,072        122,907        10,574   

Change in accounts payable and accrued liabilities

     16,212,848        107,281        (768,263     (14,025,772     19,162,261   

Gain on sale of fixed assets

     —          —          1,890        —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     35,657,676        (3,942,492     (5,110,416     (16,312,430     (3,133,672

Investing activities

          

Purchase of tangible and intangible fixed assets

     (33,963     (76,826     (18,651     (18,723     (30,994
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (33,963     (76,826     (18,651     (18,723     (30,994

Financing activities

          

Proceeds from the issuance of share capital and share premiums

     3,500,015        —          3,699,982        —          3,285,120   

Dividend Distribution

     —          —          —          (19,900,000     —     

Capital injection for future capital increases

     —          1,954,005        1,954,005        —          214,895   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     3,500,015        1,954,005        5,653,987        (19,900,000     3,500,015   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Increase (decrease) in cash and cash equivalents

     39,123,728        (2,065,313     524,920        (36,231,153     335,349   

Cash and cash equivalents at beginning of period

     762,563        2,827,876        2,302,956        39,886,291        762,563   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

   39,886,291      762,563      2,827,876      3,655,138      1,097,912   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes


EOS S.p.A.

Notes to Financial Statements

1. Nature of Business

EOS S.p.A. (“EOS” or the Company) was established in January 2006 and commenced operations in June of that year. The Company is engaged in the development of drug product candidates for the treatment of various types of cancer. Currently, the Company is focused on the development of lucitanib (also known as E-3810), an oral, small-molecule tyrosine kinase inhibitor of the Vascular Endothelial Growth Factor (VEGF) receptors 1-3 and of the Fibroblast Growth Factor (FGF) receptors 1-2. Through these inhibitory activities, lucitanib is designed to prevent the development of new blood vessels essential for tumor growth and to interfere with tumor growth in certain FGF-dependent malignancies. lucitanib is currently in Phase I/II development for the treatment of patients with advanced solid tumors.

EOS licensed global development and commercialization rights excluding China for lucitanib from Advenchen Laboratories LLC in October 2008. In September, 2012 EOS entered into a license and collaboration agreement with Les Laboratoires Servier (Servier). In exchange for an up-front license fee of €45 million paid to EOS, Servier obtained global rights to develop and commercialize lucitanib, excluding the United States, China, and Japan. Under this agreement, EOS is also entitled to receive additional payments on the achievement of various development, regulatory and commercial milestones and to royalties on sales of lucitanib by Servier. See Note 7 for further discussion of the Advenchen and Servier license agreements.

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Data

The accompanying unaudited September 30, 2013 balance sheet, the statements of operations and cash flows for the nine months ended September 30, 2013 and 2012, and the statement of stockholders’ equity for the nine months ended September 30, 2013 and the related interim information contained within the notes to the financial statements are presented in accordance with the rules and regulations of the Securities and Exchange Commission for interim financial information. In the opinion of management, the unaudited interim financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for the fair presentation of the Company’s financial position at September 30, 2013 and results of its operations and its cash flows for the nine months ended September 30, 2013 and 2012. The results for the nine months ended September 30, 2013 are not necessarily indicative of future results.


EOS S.p.A.

Notes to Financial Statements

 

Basis of Presentation

The accompanying financial statements have been prepared on the basis of the accounts of EOS for the periods presented, as approved by the Company’s Board of Directors and in accordance with the accounting standards issued by the Italian Accounting Standard Setters (“Italian Accounting Standards”). All amounts are reported in Euro. Financial information presented after December 31, 2012 is consolidated and includes the accounts and transactions of the Company’s wholly owned subsidiary, EOS CS Srl. All significant intercompany balances and transactions have been eliminated in consolidation. The financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The realization of assets and the satisfaction of liabilities in the normal course of business are dependent on, among other things, the Company’s ability to operate profitably, to generate cash flows from operations, and to pursue financing arrangements to support its working capital requirements.

The preparation of financial statements in accordance with Italian Accounting Standards requires the Company to make estimates and assumptions that affect the reported carrying amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the amounts of revenues and expenses recognized during the reporting periods. Actual results could differ from those estimated.

The principal accounting policies applied by EOS according to Italian Accounting Principles in the accompanying financial statements are summarized below.

Cash and Cash Equivalents

Cash and cash equivalents represent highly liquid investments that are readily convertible to cash and have original maturities of ninety days or less.

Receivable and Payables

Receivables are recognized at their estimated realization value while payables are stated at their nominal amount. Foreign currency transactions are initially recognized at the exchange rate in force at the transaction date. Any exchange rate gains or losses arising when receivable and payables are collected/paid are recognized in the statement of operations as financial charges. At the reporting date, any foreign currency receivable and payables are translated at the year-end exchange rate and any resulting gains or losses are recognized in the statement of operations as financial charges.


EOS S.p.A.

Notes to Financial Statements

 

Intangible Fixed Assets

Intangible fixed assets are stated at acquisition cost, including directly-related charges and net of accumulated amortization. Amortization is charged on a straight-line basis over the assets’ estimated useful lives. If, regardless of accumulated amortization, an asset is found to be impaired, it is written down to its net realizable value accordingly. Should the reasons for the impairment no long apply in future periods, the write-down is reversed to the extent of the original amount less accumulated amortization. Since the company primarily carries out research and development activities, impairment testing considers both future cash flows and the capitalized cost’s contribution to the performance of the research and development activity and the related preliminary results.

Income Taxes

Income taxes are estimated based on the expected tax charges pursuant to current tax legislation. Taxes receivable or payable are stated net of estimated payments made on account or amounts withheld for tax purposes by customers and third party vendors.

Deferred tax assets and liabilities are recognized in order to account for temporary differences between the assets’ and liabilities’ carrying amounts and their tax bases. Deferred tax assets, including those arising from tax loss and credit carry forwards are recognized only if their recoverability is reasonably certain.

Employees’ Leaving Entitlement

Employees’ leaving entitlement is calculated based on the employees’ seniority level at the reporting date, in accordance with relevant legislation and labor agreements. The amount is stated net of any advances paid and the amount accrued during the year is recognized in the statement of operations. The liability for employees’ leaving entitlement is included in other current liabilities in the accompanying balance sheet.

Recognition of Revenues and Expenses

Revenues and expenses are stated on an accrual basis, giving recognition to related prepayments, accrued income, accrued expenses and deferred income. Revenue from services is recognized when customers approve the service. Upfront or milestone payments pursuant to license agreements are recognized in the statement of operations when the contractual conditions are met. Other revenues presented on the Statement of Operations primarily represent the recharge of lucitanib development expenses incurred by the Company that are eligible for reimbursement by Servier under the license agreement.


EOS S.p.A.

Notes to Financial Statements

 

3. Cash and Cash Equivalents

Cash and cash equivalents as of September 30, 2013, December 31, 2012 and 2011 consisted of the following:

 

     September 30,
2013
(Unaudited)
     December 31,
2012
     December 31,
2011
 

Cash on hand

   3,158       1,440       1,571   

Bank current accounts

     3,651,980         1,386,432         760,992   

Deposit account

     —           30,000,000         —     

Repurchase agreements

     —           8,498,419         —     
  

 

 

    

 

 

    

 

 

 

Total

   3,655,138       39,886,291       762,563   
  

 

 

    

 

 

    

 

 

 

Funds invested in the deposit account bear interest at an annual rate of 3.69%. Repurchase agreements earned interest at an annual rate of 0.80% and matured in January 2013.

4. Accounts Receivable, Net

Accounts receivable, net of €2,017,868 as of September 30, 2013 consist primarily of amounts due from Servier as a recharge of costs incurred by the Company to develop lucitanib, pursuant to the license agreement with Servier. Accounts receivable, net of €1,049,154 as of December 31, 2012 consist primarily of amounts to be invoiced to Servier as a recharge for costs incurred by the Company to develop lucitanib, pursuant to the license agreement with Servier. Accounts receivable, net of €68,036 as of December 31, 2011 relate to amounts due from a third party for research and development services provided by EOS during 2011.

5. Other Current Receivables

Other current receivables as of September 30, 2013, December 31, 2012 and 2011 consisted of the following:

 

     September 30,
2013

(Unaudited)
     December 31,
2012
     December 31,
2011
 

VAT receivable

   472,534       680,107       979,319   

Receivable from employees and directors

     621,011         528,598         —     

Other

     85,015         5,014         116,277   
  

 

 

    

 

 

    

 

 

 

Total

   1,178,560       1,213,719       1,095,596   
  

 

 

    

 

 

    

 

 

 

The receivable from employees and directors relates to income tax withholdings made and paid by the Company on behalf of certain employees and directors which were due as a result of the exercise of stock options in 2012.


EOS S.p.A.

Notes to Financial Statements

 

6. Intangible Fixed Assets

Intangible fixed assets, net of accumulated amortization, totaled €92,318, €92,439 and €300,717 as of September 30, 2013, December 31, 2012 and 2011, respectively. The amounts consist of costs capitalized in connection with the start-up and capital increases for the Company, costs to register patentable results from the Company’s research and development activities, and costs incurred to acquire the license for lucitanib from Advenchen in 2008 (see Note 7). Amortization expense for these assets for the nine months ended September 30, 2013 and the years ended December 31, 2012, 2011, and 2010 totaled €26,016, €227,962, €247,331, and €257,373, respectively.

7. License Agreements

Advenchen Laboratories LLC

In October 2008, the Company entered into an exclusive license agreement with Advenchen Laboratories LLC to develop and commercialize lucitanib on a global basis, excluding China. Under the terms of the agreement, the Company paid Advenchen an upfront fee of €807,516 (U.S. $1,075,000) and will pay royalties on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, pursuant to the first and second amendments to the license agreement, future milestone payment terms were revised such that the Company will pay to Advenchen a percent in the mid-twenties of any sublicense milestone payments received by the Company. Pursuant to this clause, the Company accrued a liability to Advenchen of €11,250,000 as of December 31, 2012 as its portion of the €45 million upfront sublicense fee received from Servier in 2012 (see discussion below). Additional fees were paid or accrued to Advenchen during 2012 totaling €1,698,613 associated with the execution of amendments to the license agreement. As of December 31, 2012, the Company owed Advenchen €12,386,880 for these fees and milestones, all of which were paid in 2013.

Les Laboratoires Servier

In September 2012, the Company entered into a collaboration and license agreement with Les Laboratoires Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan, and China. In exchange for these rights, the Company received an upfront payment of €45 million, which is recorded as revenue in the accompanying Statement of Operations for the year ended December 31, 2012. Further, EOS will receive additional payments on the achievement of specified development, regulatory and commercial milestones and will receive royalties on sales of lucitanib by Servier. Servier is responsible for all of the global development costs for lucitanib up to €80 million, pursuant to a mutually-agreed upon development plan. Cumulative global development costs, if any, in excess of €80 million will be shared equally between the two companies. The Company charged Servier €1,013,154 for the year ended December 31, 2012 for lucitanib development expenses incurred by EOS that are eligible for reimbursement by Servier under the license agreement and the amount is recorded to other revenues in the Statement of Operations.


EOS S.p.A.

Notes to Financial Statements

 

8. Stockholders’ Equity

Share Capital

Share capital of €1,244,344 as of September 30, 2013 and December 31, 2012 and €1,029,449 as of December 31, 2011 was comprised of the following:

 

     September 30,
2013

(Unaudited)
     December 31,
2012
     December 31,
2011
 

Ordinary shares

   122,900       122,900       122,900   

Class A preferred shares

   675,536       675,536       597,521   

Class A2 preferred shares

   108,185       108,185       108,185   

Class A3 preferred shares

   200,843       200,843       200,843   

Class A4 preferred shares

   136,880       136,880       —     

All shares have a nominal amount of €1.

In May 2012, the shareholders approved a capital increase of €200,000, plus €4,800,000 as share premium, therefore totaling €5,000,000. Other shareholders waived their subscription rights to the benefit of the shareholders Lux Capital and Aescap Venture. As of December 31, 2012, that capital increase had been subscribed and paid up in two installments totaling €136,880, in addition to the related share premium of €3,285,121.

In August 2012, in compliance with authorization from the Company’s shareholders, the Board of Directors approved a capital increase of €78,015, by issuing 78,015 shares with no share premium and excluding the subscription right, pursuant to article 2441.V/VIII of the Italian Civil Code, reserved for the Company’s employees and directors benefiting from the stock option plan. This capital increase has been fully paid up.

In December 2011, the Company’s shareholders approved a capital increase of €160,757, plus €3,747,253 as share premium, therefore totaling €3,908,010, with the waiver of subscription rights by incorporating shareholders, which was proportionally subscribed and paid up by institutional shareholders by allocating capital injections already made by those shareholders.

In February 2010, the residual portion of a capital increase approved by shareholders in 2009 was subscribed and paid up for an overall amount of €3,699,981.


EOS S.p.A.

Notes to Financial Statements

 

Share Premium Reserve

The share premium reserve balance totaled €3,342,376 as of December 31, 2012. This reserve relates to the share premium paid by the shareholders in 2012 and prior years, net of the amount used to cover various years’ net losses, as approved by the Company’s shareholders. The share premium reserve balance decreased by €2,841,939 from December 31, 2011 due to the coverage of the 2011 net loss as well as losses carried forward from previous years totaling €6,127,060, partially offset by the €3,285,121 capital increase approved in May 2012.

The share premium reserve balance totaled €6,184,315 as of December 31, 2011, down €739,260 from December 31, 2010. The decrease during 2011 was due to the coverage of the 2010 net loss of €4,486,513, partially offset by the €3,747,253 capital increase approved in December 2011.

The share premium reserve balance totaled €6,923,575 as of December 31, 2010, down €1,255,529 from December 31, 2009. The decrease during 2010 was due to the coverage of the 2009 net loss of €4,803,310, partially offset by a €3,547,781 capital increase approved in July 2009.

The share premium reserve is available to increase share capital, cover losses, or for the payment of dividends.

Other Reserves

Other reserves were eliminated during 2012 to cover prior years’ net losses. The balance of €2,989,346 as of December 31, 2011 relates to capital injections made by one of the Company’s shareholders in 2007 and 2008 to support business development, as set forth in the relevant shareholder agreements.

Stockholders’ rights and preferences

The authorized capital stock of the Company consists of 122,900 Ordinary Shares and 1,121,444 Preferred Shares. The Company has authorized four series of Preferred Shares, which include 675,536 Series A Preferred Shares, 108,185 Series A2 Preferred Shares, 200,843 Series A3 Preferred Shares and 136,880 Series A4 Preferred Shares, all of which are issued and outstanding at September 30, 2013.

A detailed summary of the rights and preferences associated with the holders of the Company’s preferred shares and ordinary shares are described below.

VOTING RIGHTS

The holders of the ordinary shares are entitled to one vote per share for matters to be voted upon by the stockholders of the Company. The preferred shares have the same voting rights as the ordinary shares and are entitled to one vote per share for all matters being voted upon.

PRE-EMPTION RIGHTS

In the event the Company issues new shares, the holders of both preferred shares and ordinary shares have the pro rata right to be the first in line to purchase the new shares issued by the Company. If the pre-emption right is not exercised in full, the shareholders that have exercised their pre-emption rights can then subscribe to the residual shares on a pro rata basis before they are offered for subscription to third parties. If a shareholder intends to transfer shares to another shareholder or third party, prior to this transfer, the existing shareholders will have the first right to purchase the shares contemplated in the transfer on a pro – rata basis, subject to certain conditions.

DISTRIBUTION

Upon any distribution by the Company to the Company’s shareholders arising from (1) any voluntary Company’s share capital reduction, (b) the sale of all or substantially all of the Company’s assets (including the sale of going concerns and the sale of participations in any Company subsidiaries); (c) distribution of reserves; and (d) the Company’s liquidation, the proceeds shall be allocated as follows:

 

  1) Holders of Preferred A4 shares will receive an amount per share of up €50 per share (twice the subscription price paid);

 

  2) Holder of preferred shares other that A4 shares will receive an amount per share of up €24.31 per share (one time the subscription price paid).

These distribution rights shall remain in force as long the holders of preferred A4 shares have received in distribution €50 per share and the holders of other preferred shares (other than A4 preferred shares) have received €24.31 per share. After the distribution to the preferred shareholders, the remaining assets of the Company, if any, will be distributed ratably between all the Company’s shareholders in proportion to their shareholdings.

REDEMPTION

Holders of A2 Preferred shares have the right to redeem all their preferred A2 shares only once between the dates of June 30, 2015 and December 31, 2015. The redemption value is defined as the lower of the FMV of the shares pursuant to article 2437 of the Italian Civil Code and the total investment amount made by a named investor in the Company, however, the aggregate amount paid to the preferred A2 shareholders upon redemption shall not exceed €12.16 per share.

CONVERSION

The preferred shares are convertible into ordinary shares at a rate of one for one, at any time, upon election of greater than 50% of the holders for each class of the share. The preferred shares will automatically convert into ordinary shares on a one for one basis upon the consummation of an initial public offering that meets certain predefined capital and valuation levels.

9. Accounts Payable

Accounts payable as of September 30, 2013 and December 31, 2012 and 2011 consisted of the following:

 

     September 30,
2013

(Unaudited)
     December 31,
2012
     December 31,
2011
 

Payables to suppliers

   611,391       197,699       538,708   

Accrued expenses

     916,609         1,535,026         434,036   
  

 

 

    

 

 

    

 

 

 

Total accounts payable

   1,528,000       1,732,725       972,744   
  

 

 

    

 

 

    

 

 

 


EOS S.p.A.

Notes to Financial Statements

 

10. Taxes Payable

Taxes payable as of September 30, 2013 and December 31, 2012 and 2011 consisted of the following:

 

     September 30,
2013

(Unaudited)
     December 31,
2012
     December 31,
2011
 

IRES

   —         —         —     

IRAP

     —           1,080,856         —     

Vat Payable

     25,592         —           —     

Withholdings on employees’ wages

     16,846         461,320         38,491   

Withholdings on consultants’ fees

     3,573         4,018         5,771   
  

 

 

    

 

 

    

 

 

 

Total Taxes Payable

   46,011       1,546,194       44,262   
  

 

 

    

 

 

    

 

 

 

The increase to withholdings on employees’ wages is primarily due to withholdings made on the termination benefits paid upon the termination of employment of certain personnel and on bonuses paid to management in December 2012.

The Company currently has no pending litigation with tax authorities.

11. Other Current Liabilities

Other current liabilities as of September 30, 2013 and December 31, 2012 and 2011 consisted of the following:

 

     September 30,
2013

(Unaudited)
     December 31,
2012
     December 31,
2011
 

Payables due to employees and directors within one year

   264,856       63,707       124,693   

Social security charges payable

     5,447         148,138         63,097   

Other payables

     7,558         —           —     

Employees leaving entitlement

     2,027         2,002         12,815   
  

 

 

    

 

 

    

 

 

 

Total other current liabilities

   279,888       213,847       200,605   
  

 

 

    

 

 

    

 

 

 

Payables due to employees and directors within one year include accrued wages and salaries not yet paid, accrued holidays not yet taken, and related social security contributions.

12. Long Term Liabilities

Long term liabilities of €1,540,000 as of September 30, 2013 and December 31, 2012 represents the remaining portion of bonuses granted by the board of directors to management following the execution of the Servier license agreement (see note 7) which will be paid after December 31, 2013.


EOS S.p.A.

Notes to Financial Statements

 

13. Income Taxes

Current income tax expense for the year ended December 31, 2012 includes both Corporate Income Tax (IRES) and Regional Tax on Production Activities (IRAP). There was no tax expense for the year ended December 31, 2011 and 2010 due to net losses generated during these periods. The table below reconciles the current tax amount for the year ended December 31, 2012:

 

     Year Ended December 31, 2012  

Current Tax Expense:

  

IRES

   6,606,849   

IRAP

     1,080,856   

Deferred Tax Benefit:

  

IRES tax loss carryforward

   (6,017,755
  

 

 

 

Income Tax Expense

   1,669,950   
  

 

 

 

The reported IRES tax amount was partially offset by tax losses carried forward from prior years. Carryover losses of €21,882,744, tax effected at 27.5%, reduced IRES tax expense by €6,017,755.

Tax receivables at December 31, 2012 relate to the foreign withholdings incurred in relation to the collection of the upfront payment contractually provided for in the collaboration agreement with Servier. Based on current legislation, the tax receivables amount will be recovered by offsetting the IRES payable in the future eight years. The tax receivable at December 31, 2012 is reported net of the current year IRES tax amount of €589,094.

The Company’s deferred tax assets consist of operating loss carryforwards. The realization of the deferred asset is dependent on a number of factors, including future earnings, the timing and amount of which is uncertain. As a result, the deferred tax asset is fully offset by a valuation allowance. Provided in the table below is a summary of the deferred tax assets as of September 30, 2013 and December 31, 2012 and 2011, presented in thousands:

 

     September 30,     December 31,  
     2013
(Unaudited)
          2012            2011  

Net operating loss carryforward

   422      —               6,018   

Less: valuation allowance

   (422   —         (6,018
  

 

 

   

 

 

    

 

 

 

Net deferred tax asset

   —        —         —     
  

 

 

   

 

 

    

 

 

 

A reconciliation of the statutory income tax rate to the effective income tax rate is provided in the table below.

 

     December 31,  
     2012  

Theoretical IRES tax on income

     27.5

Non deductible expenses

     0.2

Valuation allowance

     (25.2 )% 
  

 

 

 

IRES corporate tax

     2.5
  

 

 

 

Theoretical IRAP tax on income

     3.9

Non deductible expenses

     0.6
  

 

 

 

IRAP corporate tax

     4.5
  

 

 

 

Total effective tax rate

     7.0
  

 

 

 

14. Reconciliation of differences between Italian Accounting Standards and Generally Accepted Accounting Principles in the United States of America

The financial statements of the Company have been prepared in accordance with Italian Accounting Standards as described in Note 2. Italian Accounting Standards differ in certain material respects from accounting principles generally accepted in the United States (“U.S. GAAP”). The significant differences that effect Net Income (Loss) for the years ended December 31, 2012, 2011 and 2010 and the nine months ended September 30, 2013 and 2012 and Shareholders’ Equity at December 31, 2012 and 2011 and September 30, 2013 are described below, including an explanation of the adjustments.


EOS S.p.A.

Notes to Financial Statements

 

(A) Accounting for start up, industrial patents and intellectual property rights:

Under Italian Accounting Standards, formation costs incurred during the start up phase of a new business can be capitalized if reasonable expectations exist that these costs can be recovered through future economic benefits generated by the Company. In addition, costs incurred to register the results generated from Company research and patent applications are capitalized under Italian Accounting Standards. The treatment of these costs under U.S. GAAP is to expense the costs as incurred. The following table summarizes the adjustments needed to convert the intangible assets reported by the Company into U.S. GAAP.

 

US GAAP Adjustments:   

09/30/2013

(Unaudited)

   

09/30/2012

(Unaudited)

    12/31/2012     12/31/2011     12/31/2010  

Beginning balance adjustments

   (92,071   (104,418   (104,418   (77,309   (126,177

Write-off amounts capitalized in current period

     (11,391     (14,171     (19,287     (76,216     (9,935

Reversal of Italian GAAP expense

     25,944        24,550        31,634        49,107        58,803   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

US GAAP Income Statement adjustment

     14,553        10,379        12,347        (27,109     48,868   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   (77,518   (94,039   (92,071   (104,418   (77,309
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

(B) Accounting for license acquisition:

In 2008, the Company entered into a license agreement with Advenchen to develop and commercialize lucitanib in all countries except China. The Company made an up-front payment to Advenchen which was capitalized to the balance sheet as an intangible fixed asset and is being amortized over a period of approximately five years on a straight line basis. For U.S. GAAP purposes, the acquisition of a product right that has not reached technological feasibility and does not have an alternative future use should be immediately expensed. The following table summarizes the adjustments needed to convert the capitalized intangible fixed asset reported by the Company into U.S. GAAP.

 

US GAAP Adjustments:   

09/30/2013

(Unaudited)

   

09/30/2012

(Unaudited)

    12/31/2012     12/31/2011     12/31/2010  

Beginning balance adjustments

   (368   (196,299   (196,299   (394,440   (593,010

Write-off amounts capitalized in current period

     (14,504     (199     (397     (83     —     

Reversal of Italian GAAP expense

     72        146,892        196,328        198,224        198,570   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

US GAAP Income Statement adjustment

     (14,432     146,693        195,931        198,141        198,570   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   (14,800   (49,606   (368   (196,299   (394,440
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 


EOS S.p.A.

Notes to Financial Statements

 

(C) Revenue recognition for collaboration and license arrangements:

In September 2012, the Company entered into a collaboration and license agreement with Servier to grant Servier an exclusive license to develop and commercialize lucitanib in all countries except the U.S., Japan and China. The Company retains all development and commercialization rights in the United States and Japan. Pursuant to the license agreement, Servier agreed to pay the Company milestone payments based on the achievement of specified development, regulatory and commercial milestones and will receive royalties on sales of lucitanib by Servier. Servier is responsible for all of the global development costs for lucitanib up to €80 million, pursuant to a mutually-agreed upon development plan. Cumulative global development costs, if any, in excess of €80 million will be shared equally between the two companies. Upon execution of the agreement, Servier performed an upfront cash payment of €45 million, which the Company fully recognized as revenue under Italian accounting principles. For U.S. GAAP purposes, revenue recognition associated with collaboration and license agreements with multiple revenue elements require additional analysis to determine proper revenue recognition as described below.

In accordance with ASU 2009-13, “Multiple Deliverable Revenue Arrangements”, EOS is obligated to deliver two non-contingent deliverables related to the agreement that meet the separation criteria and therefore are treated as separate units of accounting. These deliverables are (i) the exclusive commercial and development license deliverable, which includes the transfer of know-how, and (ii) participation on the joint development committee (“JDC”) to direct global development activities and collaboration efforts with Servier. The Company determined that the license has stand-alone value based on Servier’s ability to sublicense the rights to its affiliates or third parties without EOS consent. The participation on the joint development committee has stand-alone value based on our belief that the performance obligation can be performed by several experienced biopharmaceutical companies and not exclusively by EOS due to technical or specialized knowledge. The license agreement provides for no general right of return for any non-contingent deliverable. The Company identified the funding of future global development costs by Servier as a contingent deliverable because the scope, likelihood and timing of these services are uncertain.

The Company allocated consideration relating to non-contingent deliverables on the basis of their relative selling price, or best estimate of selling price (BESP), because the other methods within the accounting guidance are not applicable for these elements. The objective of BESP is to determine the price at which the Company would transact a sale to a third party if the product was sold on a stand-alone basis. BESP for the exclusive license rights is based on the discounted future projected cash flows estimated for the Servier licensed territory. Factors considered in the discounted cash flow model include estimates related to R&D development costs, revenue projections, duration of clinical testing and revenue exclusivity, clinical trial success rates within the industry and other factors. These estimates involve significant judgment and are highly subjective. Taking into account these factors, revenue of €44.2 million is allocated to the license deliverable and fully recognized for U.S. GAAP purposes in September 2012. BESP for the Company’s participation on the joint development committees is based on the contractual FTE rates agreed to by both parties under the collaboration and


EOS S.p.A.

Notes to Financial Statements

 

license agreement. Revenue of €0.8 million is allocated to the JDC participation deliverable and will be recognized ratably over the estimated global development period of 6.25 years. No portion of any revenue recognized under U.S. GAAP is refundable.

The following table summarizes the adjustment necessary to revenue as reported by the Company into U.S. GAAP.

 

US GAAP Adjustments:   

09/30/2013

(Unaudited)

    12/31/2012  

Beginning balance adjustments

   (745,920   —     

Defer development committee obligation

     —          (777,000

Recognize development committee revenue

     93,240        31,080   
  

 

 

   

 

 

 

US GAAP Income Statement adjustment

     93,240        (745,920
  

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   (652,680   (745,920
  

 

 

   

 

 

 

(D) Share-based compensation:

In 2009, the Company established the Founders’ Stock Option Plan and granted the option to purchase, in aggregate, 70,415 ordinary shares to the Company founders at an exercise price of €24.31 per share. Upon grant, the options vested immediately and were exercisable by the option holder. All options under the 2009 grant were subsequently cancelled in May 2012 and no exercises were performed while outstanding. A new option grant was then awarded to the founders in May 2012. The founders received the option to purchase, in aggregate, 78,015 preferred series A shares at an exercise price of €1.00 per share. The options vested immediately and were fully exercisable at grant date through their expiry, which will occur upon one of the following future events: (i) sale of 50% plus 1 share of the share capital, (ii) initial public offering of the Company’s shares, or (iii) distribution of the Company to shareholders resulting from (a) voluntary share capital reduction (b) sale of all or substantially all of the Company’s assets (c) distribution of reserves or (d) the Company’s liquidation. In August 2012, the founders exercised 78,015 option shares.

Under Italian GAAP, no share-based compensation expense was recognized by the Company. Under U.S. GAAP, the Company is required to recognize share-based compensation expense over the service period as defined under the terms of the option agreement. There was no service period requirement for these options resulting in the immediate recognition of compensation expense upon grant. The compensation expense is measured at the fair value using the Black-Scholes option valuation model on the grant date of the award.

Valuation assumptions

The Company calculates the fair value of each option award on the date of grant using the Black-Scholes option pricing model. The following weighted-average assumptions were used to value the options during the 2012 year:

 

Risk free interest rate

     1.02

Dividend yield

     0

Volatility

     72.9

Expected term in years

     6.3   

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for the expected life of the award. The Company’s computation of expected life and volatility was determined using peer data of companies in the biopharmaceutical industry with similar equity plans. The Company has never paid cash dividends and does not currently intend to pay cash dividends, thus has assumed a 0% dividend yield. Determination of these assumptions involves management judgement and impacts the fair value of the awards calculated under the Black-Scholes methodology.

The following table summarizes the adjustment necessary to operating expenses reported by the Company to reflect share-based compensation expense as required under U.S. GAAP.


EOS S.p.A.

Notes to Financial Statements

 

US GAAP Adjustments:   

9/30/2012

(Unaudited)

    12/31/2012  

Beginning balance adjustments

   —        —     

Recognize share-based compensation

     (1,352,620     (1,352,620
  

 

 

   

 

 

 

US GAAP Income Statement adjustment

     (1,352,620     (1,352,620

Increase to additional paid in capital

     1,352,620        1,352,620   
  

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   —        —     
  

 

 

   

 

 

 

(E) Tax receivables and income taxes:

In 2012, the Company entered into a collaboration and license agreement with Servier, as more fully discussed under section (C) above. A portion of the upfront payment made by Servier to EOS was subject to withholding by a foreign jurisdiction in the amount of €2,250,000. Based on current Italian legislation, a credit of €2,250,000 was generated that can be applied against current and future IRES tax liabilities generated from operations for a period of eight years. The Company utilized €589,094 of the credits during the year ended December 31, 2012, and has €1,660,906 of credit remaining.

Under Italian Accounting Principles, this credit is presented as a tax receivable and has not been impaired considering the possibility of its recoverability as an offset against future IRES tax liabilities. Under U.S. GAAP, considering the substance of this item which cannot be collected in cash, it would be presented as a deferred tax asset. The future realization of this deferred tax asset is uncertain and it does not meet the more likely than not criteria resulting in a full valuation allowance of the asset for U.S. GAAP purposes.

Under Italian Accounting Principles, the foreign withholding tax and related Italian tax credit described above are not presented as income tax expense or benefit. Under US GAAP, the foreign withholding tax of €2,250,000 would be presented as a foreign current income tax expense. The portion of the Italian tax credit utilized during the year would be presented as reduction to Italian current income tax expense and no tax benefit would be recognized for the remaining credit under U.S. GAAP.

Under Italian Accounting Principles, current tax expense is recognized for the tax expense that would be owed if it were not offset by operating loss carryforwards and tax credits. Accordingly, the company presented under note 13, the IRES tax charge of €6,606,849 as current tax expense. The related utilization of previously unrecognized beginning-of-year deferred tax assets for operating loss carryforwards of €6,017,755 was presented as a deferred tax benefit. Under U.S. GAAP, there would be no IRES tax expense presented. Consequently, under U.S. GAAP, the income tax expense for the year ended December 31, 2012 would be composed of €1,080,856 of IRAP and €2,250,000 of current foreign withholding taxes.

The following table summarizes the adjustment necessary to report the impairment of the deferred tax asset under U.S. GAAP.

 

US GAAP Adjustments:   

9/30/2013

(Unaudited)

   

9/30/2012

(Unaudited)

    12/31/2012  

Beginning balance adjustments

   (1,661,260   —        —     

Write-off amounts capitalized in current period

     354        (1,661,260     (1,661,260
  

 

 

   

 

 

   

 

 

 

US GAAP Income Statement adjustment

     354        (1,661,260     (1,661,260
  

 

 

   

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   (1,660,906   (1,661,260   (1,661,260
  

 

 

   

 

 

   

 

 

 

(F) Redeemable preferred stock:

Based on the terms stated within the Company’s By-Laws, the holders of series A2 preferred shares have the right to redeem their shares with the Company for cash settlement between the dates of June 30, 2015 and December 31, 2015. The redemption value is defined as the lower of the fair market value of the shares pursuant to article 2437 of the Italian Civil Code and the total investment amount made by a named investor in the Company, however, the aggregate amount paid to the preferred A2 shareholders upon redemption shall not exceed €12.16 per share. Under U.S. GAAP, equity instruments for which redemption of an equity security is at the option of the holder and does not meet liability classification


EOS S.p.A.

Notes to Financial Statements

 

requirements, will be reported as a temporary equity item between the liability and equity sections on the balance sheet. The value to be reported as temporary equity is the transaction price of the instrument, which approximates fair value on the date of issuance. The following table summarizes the adjustment necessary to report reclassification of the preferred A2 shares to temporary equity under U.S. GAAP.

 

US GAAP Adjustments:   

9/30/2013

(Unaudited)

   

9/30/2012

(Unaudited)

    12/31/2012     12/31/2011  

Beginning balance adjustments

   (2,629,977   (2,629,977   (2,629,977   —     

Reclassify A2 preferred share redemption value to temporary equity

     —          —          —          (2,629,977
  

 

 

   

 

 

   

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   (2,629,977   (2,629,977   (2,629,977   (2,629,977
  

 

 

   

 

 

   

 

 

   

 

 

 

(G) Reimbursement of collaborative development costs:

Under the license agreement with Servier, the first €80 million of research and development costs incurred pursuant to the agreed upon global development plan for lucitanib is the responsibility of Servier. The Company sponsored an early stage clinical trial related to lucitanib and the cost of this trial, which was included in the mutually agreed upon global development plan, is being reimbursed by Servier. Under Italian GAAP, the reimbursement from Servier is reported on a gross basis as other revenue to the statement of operations. Under U.S. GAAP, the Company has the ability to report the reimbursement of collaborative expenses on a net basis against R&D expense per ASC 808-10, “Accounting for Collaborative Arrangements.” The following table summarizes effects of the reduction to revenue and research and development expenses related to the reimbursement of development costs by Servier under U.S. GAAP.

 

US GAAP Adjustments:   

9/30/2013

(Unaudited)

    12/31/2012  

Beginning balance adjustments

   —        —     

Decrease to other income

     (2,425,011     (1,013,154

Decrease to R&D expense

     2,425,011        1,013,154   
  

 

 

   

 

 

 

US GAAP Income Statement adjustment

     —          —     
  

 

 

   

 

 

 

US GAAP shareholders’ equity adjustment

   —        —     
  

 

 

   

 

 

 


EOS S.p.A.

Notes to Financial Statements

 

The following table summarizes the significant adjustments necessary to reconcile the net income (loss) reported by the Company under Italian Accounting Principles to U.S GAAP for the nine months ended September 30, 2013 and 2012 and for the years ended December 31, 2012, 2011 and 2010.

 

     Nine Months Ended September 30,     Year Ended December 31,  
Description    2013
(Unaudited)
    2012
(Unaudited)
    2012     2011     2010  

Net income (loss) per Italian Accounting Principles

   (1,534,013   22,947,679      22,145,545      (4,703,720   (4,486,513

Accounting for startup, patents and intellectual property rights

     14,553        10,379        12,347        (27,109     48,868   

Accounting for license acquisition

     (14,432     146,693        195,931        198,141        198,570   

Revenue recognition from collaboration and license arrangement

     93,240        —          (745,920     —          —     

Impairment of deferred tax asset

     354        (1,661,260     (1,661,260     —          —     

Share-based compensation

     —          (1,352,620     (1,352,620     —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

U.S. GAAP Adjustments

     93,715        (2,856,808     (3,551,522     171,032        247,438   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) in accordance with U.S. GAAP

   (1,440,298   20,090,871      18,594,023      (4,532,688   (4,239,075
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

There is no net tax effect to the pre tax reconciling items as there would be an offsetting adjustment to the Company’s net deferred tax asset valuation allowance.

The following table summarizes the significant adjustments necessary to reconcile Stockholders’ Equity reported by the Company under Italian Accounting Principles to U.S GAAP as of September 30, 2013 and December 31, 2012 and 2011.

 

     September 30,     December 31,  
Description    2013
(Unaudited)
    2012     2011  

Stockholders’ Equity per Italian Accounting Principles

   5,298,251      26,732,265      1,086,704   

Accounting for startup, patents and intellectual property rights

     (77,518     (92,071     (104,418

Accounting for license acquisition

     (14,800     (368     (196,299

Revenue recognition from collaboration and license arrangement

     (652,680     (745,920     —     

Impairment of deferred tax asset

     (1,660,906     (1,661,260     —     

Reclass A2 preferred shares to temporary equity

     (2,629,977     (2,629,977     (2,629,977
  

 

 

   

 

 

   

 

 

 

U.S. GAAP Adjustments

     (5,035,881     (5,129,596     (2,930,694
  

 

 

   

 

 

   

 

 

 

Stockholders’ Equity in accordance with U.S. GAAP

   262,370      21,602,669      (1,843,990
  

 

 

   

 

 

   

 

 

 

EXHIBIT 99.2

Clovis Oncology, Inc.

Pro Forma Unaudited Combined Financial Statements

On November 19, 2013, Clovis Oncology, Inc. (the “Company”) purchased 100% of the ordinary and preferred shares outstanding of EOS S.p.A. (“EOS”) through the issuance of common stock, an upfront cash payment and future contingent consideration payable to EOS shareholders.

The following unaudited pro forma combined statements of operations for the nine months ended September 30, 2013 and the year ended December 31, 2012 are prepared as if the acquisition transaction occurred on January 1, 2012. The unaudited pro forma combined balance sheet as of September 30, 2013 is prepared as if the acquisition transaction occurred on the balance sheet date. The unaudited pro forma combined financial statements reflect the acquisition transactions using pro forma adjustments applied to the historical consolidated financial statements of the Company and EOS.

The business combination will be accounted for in accordance with the acquisition method of accounting. Under this method, the purchase price to acquire EOS is allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the acquisition date. If the purchase price is in excess of the estimated fair value of the net assets acquired, including both the tangible and identifiable intangible items, the difference is assigned to goodwill.

The Company’s process for estimating the fair value of acquired assets and liabilities is complex, requiring the assistance of a valuation specialist, extensive use of prospective financial information and management judgment. The allocation of the purchase price also requires extensive use of accounting estimates and judgments. Accordingly, the purchase price allocation provided within the unaudited pro forma combined financial statements is preliminary and may be adjusted if new or better information comes to light related to the valuation assumptions or accounting information. These adjustments may be significant. The final valuation and purchase price allocation is expected to be completed as soon as possible after the close of the transaction but no later than 12 months after the acquisition.

The unaudited pro forma combined financial information includes historical financial information for the Company and EOS. The Company’s historical consolidated balance sheet as of September 30, 2013 and its historical consolidated statement of operations for the nine months ended September 30, 2013 were obtained from the unaudited consolidated financial statements reported on Form 10-Q for the quarter ended September 30, 2013. The Company’s historical consolidated statement of operations for the year ended December 31, 2012 was obtained from the audited consolidated financial statements reported on Form 10-K for the year ended December 31, 2012. The EOS unaudited historical balance sheet as of September 30, 2013 and unaudited statement of operations for the nine month period ended September 30, 2013 were provided by EOS management and are included as an exhibit to our Current Report on Form 8-K. The audited statement of operations for the year ended December 31, 2012 is included as an exhibit to this Current Report on Form 8-K. The EOS statements were originally reported under accounting principles provided by the Italian Accountancy Body (“Italian GAAP”) and were converted to U.S GAAP for the pro forma presentation. The historical statements of operations were translated from Euros to US dollars using the average foreign exchange rates of $1.317 during the nine months ended September 30, 2013 and $1.286 during the year ended December 31, 2012. The EOS balance sheet as of September 30, 2013 was translated from Euros into U.S. dollars using the foreign exchange spot rate at September 30, 2013 of $1.352.


The estimated purchase price of $254.9 million is comprised of an immediate upfront cash payment of $10.0 million paid at closing, the issuance of Clovis common stock with a market value of $190.0 million delivered at closing and estimated contingent purchase consideration of $54.9 million that will be paid to EOS shareholders based on the achievement of future development and commercial milestones.

The Company and EOS recorded an aggregate of approximately $0.8 million in acquisition related costs, including legal, accounting and advisory services in its statement of operations during the nine months ended September 30, 2013. The acquisition related amounts have been eliminated from the September 30, 2013 pro forma combined statements of operations as they are non recurring.

The unaudited pro forma financial information is presented for illustrative purposes only. This information is not necessarily indicative of the financial position or results of operations that would have been reported had the acquisition actually occurred at the beginning of the periods presented or at the balance sheet date and they are not indicative of our future financial position or results of operations. The pro forma adjustments give effect to (i) the preliminary estimated allocation of the acquisition purchase price, (ii) the issuance of approximately 3.7 million shares of Clovis Oncology, Inc. common stock, (iii) an upfront payment of $10.0 million dollars for the acquisition, (iv) fair value of contingent purchase consideration at acquisition date, and (v) the elimination of non recurring acquisition costs. This unaudited pro forma financial information does not include, nor does it assume, any benefits from cost savings or synergies of the combined operations. The pro forma adjustments are based upon available information at this time and assumptions that we believe are reasonable. The unaudited pro forma financial information should be read in conjunction with the historical consolidated financial statements and notes thereto for the Company included on its Form 10-Q for the quarter ended September 30, 2013 and its Form 10-K for the year ended December 31, 2012 and with the historical audited financial statements of EOS S.p.A included elsewhere in this Current Report on Form 8-K. A reconciliation of consolidated net income and shareholders’ equity between Italian GAAP and U.S. GAAP are included under note 14 within the historical financial statements.


Clovis Oncology, Inc.

(a development stage enterprise)

Unaudited Pro Forma Combined Balance Sheets

At September 30, 2013

(In thousands, except for share amounts)

 

     Historical     Pro Forma  
          

EOS

S.p.A.

             
     Clovis
Oncology,
Inc .
    (Presented in
U.S. GAAP)
    Adjustments     Combined  
ASSETS         

Current assets:

        

Cash and cash equivalents

   $ 356,624      $ 4,943      $ (10,000 )(A)    $ 351,567   

Accounts receivable, net

     —          2,729        —          2,729   

Prepaid research and development expenses

     1,167        —          —          1,167   

Other current assets

     727        1,688        —          2,415   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total current assets

     358,518        9,360        (10,000     357,878   

Property and equipment, net

     988        24        —          1,012   

Intangible assets

     —          —          248,600 (B)      248,600   

Goodwill

     —          —          2,388 (C)      2,388   

Other assets

     753        —          —          753   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total assets

   $ 360,259      $ 9,384      $ 240,988      $ 610,631   
  

 

 

   

 

 

   

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY         

Current liabilities:

        

Accounts payable

   $ 880      $ 2,066      $ —        $ 2,946   

Accrued research and development expenses

     10,916        —          —          10,916   

Other accrued expenses

     2,783        609        —          3,392   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total current liabilities

     14,579        2,675        —          17,254   

Non-current liabilities

     150        2,797        —          2,947   

Contingent consideration

     —          —          54,900 (D)      54,900   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities

     14,729        5,472        54,900        75,101   

Commitments and contingencies

        

Series A-2 redeemable preferred stock

     —          3,557        (3,557 )(E)      —     

Stockholders’ equity:

        

Preferred Stock, par value $0.001 per share; 10,000,000 shares authorized, and no issued and outstanding at September 30, 2013

     —          —          —          —     

Common stock, $0.001 par value per share, 100,000,000 shares authorized at September 30, 2013 and 33,774,420 proforma shares issued and outstanding at September 30, 2013

     30        —          4 (A)      34   

EOS S.p.A. share capital

     —          1,683        (1,683 )(E)      —     

Additional paid-in capital

     585,243        31,291        158,705 (A),(E)      775,239   

Accumulated other comprehensive income

     68        939        (939 )(E)      68   

Deficit accumulated during development stage

     (239,811     (33,558     33,558 (E)      (239,811
  

 

 

   

 

 

   

 

 

   

 

 

 

Total stockholders’ equity

     345,530        355        189,645        535,530   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 360,259      $ 9,384      $ 240,988      $ 610,631   
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes


Clovis Oncology, Inc.

(a development stage enterprise)

Unaudited Pro Forma Consolidated Statements of Operations

For the nine months ended September 30, 2013

(In thousands, except per share amounts)

 

     Historical     Pro Forma  
           EOS S.p.A.              
     Clovis
Oncology,
Inc .
    (Presented in
U.S. GAAP)
    Adjustments     Combined  

Revenues:

        

License fees

   $ —        $ 123      $ —        $ 123   

Expenses:

        

Research and development

     44,001        280        —          44,281   

General and administrative

     11,022        1,809        (776 )(F)      12,055   

Acquired in-process research and development

     250        —          —          250   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total expenses

     55,273        2,089        (776     56,586   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (55,273     (1,966     776        (56,463

Other income (expense), net

     (56     69        —          13   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (55,329     (1,897     776        (56,450

Income taxes

     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (55,329   $ (1,897   $ 776      $ (56,450
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (2.00       $ (1.80
  

 

 

       

 

 

 

Basic and diluted weighted average common shares outstanding

     27,614          3,714        31,328   

See accompanying notes


Clovis Oncology, Inc.

(a development stage enterprise)

Unaudited Consolidated Statements of Operations

For the year ended December 31, 2012

(In thousands, except per share amounts)

 

     Historical     Pro Forma  
           EOS S.p.A.               
     Clovis
Oncology,
Inc .
    (Presented in
U.S. GAAP)
    Adjustments      Combined  

Revenues

         

License fees

   $ —        $ 56,906      $ —         $ 56,906   

Other revenues

     —          162        —           162   
  

 

 

   

 

 

   

 

 

    

 

 

 

Total revenues

     —          57,068        —           57,068   
  

 

 

   

 

 

   

 

 

    

 

 

 

Expenses:

         

License fees

     —          16,651        —           16,651   

Research and development

     58,894        9,353        —           68,247   

General and administrative

     10,638        3,104        —           13,742   

Acquired in-process research and development

     4,250        —          —           4,250   
  

 

 

   

 

 

   

 

 

    

 

 

 

Total expenses

     73,782        29,108        —           102,890   
  

 

 

   

 

 

   

 

 

    

 

 

 

Operating (loss) income

     (73,782     27,960        —           (45,822

Other income (expense), net

     (228     233        —           5   
  

 

 

   

 

 

   

 

 

    

 

 

 

Loss before income taxes

     (74,010     28,193        —           (45,817

Income taxes

     27        (4,283     —           (4,256
  

 

 

   

 

 

   

 

 

    

 

 

 

Net loss

   $ (73,983   $ 23,910      $ —         $ (50,073
  

 

 

   

 

 

   

 

 

    

 

 

 

Basic and diluted net loss per common share

   $ (2.97        $ (1.75
  

 

 

        

 

 

 

Basic and diluted weighted average common shares outstanding

     24,915          3,714         28,629   

See accompanying notes


Clovis Oncology, Inc.

Notes to the Unaudited Pro Forma Combined Financial Statements

 

1. Description of Acquisition and Basis of Presentation

On November 19, 2013, Clovis Oncology, Inc. (the “Company”) purchased 100% of the ordinary and preferred shares outstanding of EOS S.p.A. (“EOS”) through the issuance of common stock, an upfront cash payment and future contingent consideration payable to EOS shareholders. Approximately $0.8 million in acquisition related costs were incurred in the nine months ended September 30, 2013 by the Company and EOS to complete the acquisition, which primarily relate to legal, accounting and advisory services. Total acquisition costs of $2.6 million are expected to be incurred on a combined basis to complete the purchase acquisition.

The acquisition will be accounted for under U.S. GAAP, using the acquisition method of accounting. Under this method, the purchase price to acquire 100% ownership in EOS is allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values on the acquisition date. If the purchase price is in excess of the estimated fair value of the net assets acquired, the difference is assigned to goodwill.

The allocation of the purchase price is based on preliminary estimates of the fair value made solely for the purpose of preparing the pro forma statements. The actual allocation of the purchase price may differ significantly from the preliminary estimated allocation due to adjustments to the fair value of the Company’s common stock to be used as consideration in the purchase, actual balances of tangible assets and liabilities acquired at the acquisition date, and refinement to the fair values of the net assets acquired and liabilities assumed. Based on fair value estimates by management with the assistance of a valuation specialist, the preliminary purchase price has been allocated to individual assets acquired and liabilities assumed as of the closing date as follows:

 

     Presented in US Dollars
(in thousands)
 

Estimated purchase price:

  

Cash

   $ 10,000   

Issuance of Clovis Oncology, Inc. common stock (1)

     190,000   

Fair value of contingent purchase consideration (2)

     54,900   
  

 

 

 

Total estimated purchase price

   $ 254,900   
  

 

 

 

Asssets and liabilities acquired:

  

Net assets of EOS S.p.A. (3)

   $ 3,912   

Fair value of Servier licensed technology (4)

     57,100   

Fair value of lucitanib development and commercial rights (5)

     191,500   

Goodwill

     2,388   
  

 

 

 

Total estimated fair value of assets and liabilities acquired

   $ 254,900   
  

 

 

 

 

(1) The number of Clovis Oncology, Inc. shares issued to consummate the acquisition was 3.7 million shares, having an agreed fair market value of approximately $51.16 dollars per share at closing.


Clovis Oncology, Inc.

Notes to the Unaudited Pro Forma Combined Financial Statements

 

(2) The Company will pay up to approximately $220 million to EOS shareholders upon the achievement of certain future development and commercial milestones. U.S. GAAP requires the recognition of the contingent consideration as part of the purchase consideration and is valued at its fair value as of the acquisition date. The fair value of the contingent consideration is based on the discounting of the milestone payments from the estimated milestone achievement date to the acquisition date using an estimated borrowing rate after applying a probability of success factor to each milestone payment.
(3) The net carrying value of the net assets and liabilities acquired approximate fair value.
(4) As part of the purchase transaction, the Company acquired the right to receive future development and commercial milestone payments and royalty payments from Servier associated with sales of lucitanib, if achieved. The potential future payments are defined in the collaboration and license agreement executed in September 2012 whereby EOS sublicensed the lucitanib development and commercialization rights to Servier in all countries except the U.S., Japan and China. The fair value of this intangible asset at acquisition date was estimated using a probability weighted discounted cash flow model. The significant assumptions used to determine the acquisition date fair value include the timing and cost of clinical development, probability of success for each clinical development stage, estimated revenues, estimated selling costs and the discount factor, among other factors.
(5) In the purchase transaction, the Company acquired the right to develop and commercialize lucitanib in the U.S. and Japan or sublicense the rights to another party. The fair value of this intangible asset at acquisition date was estimated using a probability weighted discounted cash flow model. The significant assumptions used to determine the acquisition date fair value include the timing and cost of clinical development, probability of success for each clinical development stage, estimated revenues, estimated selling costs and the discount factor, among other factors.

 

2. Historical financial statements of EOS S.p.A.

The historical financial statements of EOS are prepared in accordance with Italian GAAP are included as a separate exhibit elsewhere in this Current Report on Form 8-K. A reconciliation of consolidated net (loss) income and shareholders’ equity between Italian GAAP and U.S. GAAP are included under note 14 within the historical financial statements. The EOS unaudited pro forma combined balance sheet as of September 30, 2013 was derived from the historical financial statements and was translated from Euros to U.S. dollars using a foreign exchange spot rate at September 30, 2013 of $1.352. The unaudited pro forma combined statement of operations for the nine months ended September 30, 2013 and for the year ended December 31, 2012 were derived from the historical financial statements and was translated from Euros to U.S. Dollars using the average foreign exchange rates applicable to each time period reported of $1.317 and $1.286, respectively.


Clovis Oncology, Inc.

Notes to the Unaudited Pro Forma Combined Financial Statements

 

3. Pro Forma Adjustments

 

(A) Adjustment represents the initial purchase consideration paid by the Company to acquire all the outstanding equity securities of EOS for $10.0 million of the Company’s cash and the issuance of approximately 3.7 million shares of common stock. The value of the Company’s common stock on issuance was $190 million. The purchase price may change at closing based on the level of EOS working capital acquired. For pro forma purposes, no working capital adjustment was assumed.

 

(B) Adjustment represents the estimated fair value of the sublicensed Servier technology and the Company’s acquisition of the rights to develop and commercialize lucitanib in the U.S. and Japan. The valuations were derived from probability weighted cash flow models and are subject to significant judgment and accounting estimates. The intangible assets will not be depreciated until such time they are successfully developed and we achieve regulatory approval. The assets are subject to impairment testing at least annually and if an adverse event or circumstances change that cause the fair value to decrease, the carrying value will be impaired down to the new estimated fair value.

 

(C) Adjustment represents the estimated goodwill resulting from the excess purchase price over the amounts allocated to the fair value of the tangible and intangible assets acquired and liabilities assumed in the acquisition. Goodwill will be tested for impairment at least annually or more frequently if an event occurs or circumstances change that would reduce the fair value of a reporting unit below its carrying value.

 

(D) The Company will pay up to approximately $220 million to EOS shareholders upon the achievement of certain future lucitanib development and commercial milestones, if achieved. This adjustment represents the estimated fair market value of these contingent consideration payments as of the acquisition date.

 

(E) Adjustment represents the elimination of all components of the historical equity of EOS.

 

(F) Adjustment reflects the elimination of costs incurred to support the acquisition due diligence by the Company and EOS during the nine months ended September 30, 2013.